A randomized, controlled trial of quadriceps resistance exercise and vitamin D in frail older people: the Frailty Interventions Trial in Elderly Subjects (FITNESS). Does vitamin D stop inpatients falling? A randomised controlled trial. Should older people in residential care receive vitamin D to prevent falls? Results of a randomized trial. A higher dose of vitamin d reduces the risk of falls in nursing home residents: a randomized, multiple-dose study. Vitamin D supplementation improves neuromuscular function in older people who fall. Vitamin D supplementation and the prevention of fractures and falls: results of a randomised trial in elderly people in residential accommodation. Low-dose vitamin D prevents muscular atrophy and reduces falls and hip fractures in women after stroke: a randomized controlled trial. Preventing fractures among older people living in institutional care: a pragmatic randomised double blind placebo controlled trial of vitamin D supplementation. Multivitamin supplementation improves nutritional status and bone quality in aged care residents. Effects of vitamin D and calcium supplementation on falls: a randomized controlled trial. Do vitamin D supplements improve the physical capabilities of elderly hospital patients? Effects of exercise and nutrition on postural balance and risk of falling in elderly people with decreased bone mineral density: randomized controlled trial pilot study. A cluster randomised controlled trial to prevent injury due to falls in a residential aged care population. Effects of a long-term vitamin D and calcium supplementation on falls and parameters of muscle function in community-dwelling older individuals. Effectiveness of targeted falls prevention programme in subacute hospital setting: randomised controlled trial. Randomised controlled trial of prevention of falls in people aged > or =75 with severe visual impairment: the VIP trial. Can vitamin D supplementation reduce the risk of fracture in the elderly? A randomized controlled trial. Does daily vitamin D 800 IU and calcium 1000 mg supplementation decrease the risk of falling in ambulatory women aged 65-71 years? A 3-year randomized population-based trial (OSTPRE-FPS). A multicentre randomised controlled trial of day hospital-based falls prevention programme for a screened population of community-dwelling older people at high risk of falls. A randomised, controlled comparison of different calcium and vitamin D supplementation regimens in elderly women after hip fracture: The Nottingham Neck of Femur (NONOF) Study. Should oral nutritional supplementation be given to undernourished older people upon hospital discharge? A controlled trial. Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial. Cluster randomised trial of a targeted multifactorial intervention to prevent falls among older people in hospital. Lack of effectiveness of a multidisciplinary fall-prevention program in elderly people at risk: a randomized, controlled trial. Does increased sunlight exposure work as a strategy to improve vitamin D status in the elderly: a cluster randomised controlled trial. Fall and injury prevention in older people living in residential care facilities. A cluster randomized trial. Vitamin D supplementation and fracture incidence in elderly persons. A randomized, placebo-controlled clinical trial. Evaluating the use of a targeted multiple intervention strategy in reducing patient falls in an acute care hospital: a randomized controlled trial. Should the food intake of patients admitted to acute hospital services be routinely supplemented? A randomized placebo controlled trial. Multifactorial intervention to reduce falls in older people at high risk of recurrent falls: a randomized controlled trial. Effect of annual intramuscular vitamin D on fracture risk in elderly men and women--a population-based, randomized, double-blind, placebo-controlled trial. Vitamin D and calcium supplementation prevents osteoporotic fractures in elderly community dwelling residents: a pragmatic population-based 3-year intervention study. The effects of vitamin D supplementation on physical function and quality of life in older patients with heart failure: a randomized controlled trial. A positive dose-response effect of vitamin D supplementation on site-specific bone mineral augmentation in adolescent girls: a double-blinded randomized placebo-controlled 1-year intervention. Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care. Effect of periodic vitamin A supplementation on mortality and morbidity of human immunodeficiency virus-infected children in Uganda: A controlled clinical trial. Randomized trial of domiciliary versus center-based rehabilitation: which is more effective in reducing falls and improving quality of life in older fallers? Vitamin A supplementation and severity of pneumonia in children admitted to the hospital in Dar es Salaam, Tanzania. Effects of a multifactorial falls prevention program for people with stroke returning home after rehabilitation: a randomized controlled trial. Double blind study on the need for vitamin D supplementation in prepubertal children. Effect of four monthly oral vitamin D3 (cholecalciferol) supplementation on fractures and mortality in men and women living in the community: randomised double blind controlled trial. Effectiveness of a video-based exercise programme to reduce falls and improve health-related quality of life among older adults discharged from hospital: a pilot randomized controlled trial. Impact of a fall prevention programme in acute hospital settings in Singapore. Randomized trial of alendronate plus vitamin D3 versus standard care in osteoporotic postmenopausal women with vitamin D insufficiency. Patients with recurrent falls attending Accident & Emergency benefit from multifactorial intervention--a randomised controlled trial. An outpatient multifactorial falls prevention intervention does not reduce falls in high-risk elderly Danes. Effects of a short-term vitamin D and calcium supplementation on body sway and secondary hyperparathyroidism in elderly women. Effect of multivitamin and mineral supplementation on episodes of infection in nursing home residents: a randomized, placebo-controlled study. Vitamin D3 and calcium to prevent hip fractures in the elderly women. Multifactorial fall prevention for pairs of frail community-dwelling older fallers and their informal caregivers: a dead end for complex interventions in the frailest fallers. Clinical trial of vitamin A supplementation in infants susceptible to bronchopulmonary dysplasia. Effect of vitamin D replacement on musculoskeletal parameters in school children: a randomized controlled trial. Educating nursing home staff on fracture prevention: a cluster randomised trial. An open-label trial comparing alendronate and alphacalcidol in reducing falls and hip fractures in disabled stroke patients.
To determine the effectiveness of vitamin D and home-based quadriceps resistance exercise on reducing falls and improving the physical health of frail older people after hospital discharge.
                Multicenter, randomized, controlled trial with a factorial design.
                Five hospitals in Auckland, New Zealand, and Sydney, Australia.
                Two hundred forty-three frail older people.
                Patients were randomized to receive a single dose of vitamin D (calciferol, 300,000 IU) or placebo tablets and 10 weeks of high-intensity home-based quadriceps resistance exercise or frequency-matched visits.
                The primary endpoints were physical health according to the short-form health survey at 3 months and falls over 6 months. Physical performance and self-rated function were secondary endpoints. Assessments took place in the participants' homes at 3 and 6 months after randomization and were performed by blinded assessors.
                There was no effect of either intervention on physical health or falls, but patients in the exercise group were at increased risk of musculoskeletal injury (risk ratio = 3.6, 95% confidence interval = 1.5-8.0). Vitamin D supplementation did not improve physical performance, even in those who were vitamin D deficient (<12 ng/mL) at baseline.
                Neither vitamin D supplementation nor a home-based program of high-intensity quadriceps resistance exercise improved rehabilitation outcomes in frail older people after hospitalization. There was no effect of vitamin D on physical performance, and the exercises increased the risk of musculoskeletal injury. These findings do not support the routine use of these interventions at these dosages in the rehabilitation of frail older people. Vitamin D deficiency is common in older people and may increase risk of falls and fracture. Hospital inpatients are at particular risk of falling. Previous studies suggest that vitamin D improves neuromuscular function and reduces falls.
                To determine whether routine supplementation with vitamin D plus calcium reduces numbers of fallers and falls in a cohort of hospital admissions while they are inpatients.
                Randomised, double-blind, controlled study. Participants: two hundred and five acute admissions >65 years to a geriatric medical unit.
                Patients were randomised to intervention of daily vitamin D 800 iu plus calcium 1,200 mg or control group of daily calcium 1,200 mg, until discharge or death.
                Baseline characteristics were similar in both groups with a median age 84 years and a median length of stay = 30 days (IQR 14.75-71.00). In a pre-selected sub-group (54/205 participants), median admission vitamin D level = 22.00 nmol/l (IQR 15.00-30.50). This did not significantly increase in the treatment versus control group. Median study drug adherence = 88%, with no significant difference between study groups (Mann-Whitney: P = 0.711). Although there were fewer fallers in the vitamin D cohort, this did not reach statistical significance (vitamin D: calcium = 36:45 fallers; RR 0.82 (CI 0.59-1.16). Neither the mean number of falls (vitamin D: calcium = 1.040:1.155; Mann-Whitney P = 0.435) or time to first fall (Log-rank test P = 0.377) differed between groups.
                In a population of geriatric hospital inpatients, vitamin D did not reduce the number of fallers. Routine supplementation cannot be recommended to reduce falls in this group. To determine whether vitamin D supplementation can reduce the incidence of falls and fractures in older people in residential care who are not classically vitamin D deficient.
                Randomized, placebo-controlled double-blind, trial of 2 years' duration.
                Multicenter study in 60 hostels (assisted living facilities) and 89 nursing homes across Australia.
                Six hundred twenty-five residents (mean age 83.4) with serum 25-hydroxyvitamin D levels between 25 and 90 nmol/L.
                Vitamin D supplementation (ergocalciferol, initially 10,000 IU given once weekly and then 1,000 IU daily) or placebo for 2 years. All subjects received 600 mg of elemental calcium daily as calcium carbonate.
                Falls and fractures recorded prospectively in study diaries by care staff.
                The vitamin D and placebo groups had similar baseline characteristics. In intention-to-treat analysis, the incident rate ratio for falling was 0.73 (95% confidence interval (CI)=0.57-0.95). The odds ratio for ever falling was 0.82 (95% CI=0.59-1.12) and for ever fracturing was 0.69 (95% CI=0.40-1.18). An a priori subgroup analysis of subjects who took at least half the prescribed capsules (n=540), demonstrated an incident rate ratio for falls of 0.63 (95% CI=0.48-0.82), an odds ratio (OR) for ever falling of 0.70 (95% CI=0.50-0.99), and an OR for ever fracturing of 0.68 (95% CI=0.38-1.22).
                Older people in residential care can reduce their incidence of falls if they take a vitamin D supplement for 2 years even if they are not initially classically vitamin D deficient. To determine the effect of four vitamin D supplement doses on falls risk in elderly nursing home residents.
                Secondary data analysis of a previously conducted randomized clinical trial.
                Seven hundred twenty-five-bed long-term care facility.
                One hundred twenty-four nursing home residents (average age 89).
                Participants were randomly assigned to receive one of four vitamin D supplement doses (200 IU, 400 IU, 600 IU, or 800 IU) or placebo daily for 5 months.
                Number of fallers and number of falls assessed using facility incident tracking database.
                Over the 5-month study period, the proportion of participants with falls was 44% in the placebo group (11/25), 58% (15/26) in the 200 IU group, 60% (15/25) in the 400 IU group, 60% (15/25) in the 600 IU group, and 20% (5/23) in the 800 IU group. Participants in the 800 IU group had a 72% lower adjusted-incidence rate ratio of falls than those taking placebo over the 5 months (rate ratio=0.28; 95% confidence interval=0.11-0.75). No significant differences were observed for the adjusted fall rates compared to placebo in any of the other supplement groups.
                Nursing home residents in the highest vitamin D group (800 IU) had a lower number of fallers and a lower incidence rate of falls over 5 months than those taking lower doses. Adequate vitamin D supplementation in elderly nursing home residents could reduce the number of falls experienced by this high falls risk group. vitamin D supplementation reduces the incidence of fractures in older adults. This may be partly mediated by effects of vitamin D on neuromuscular function.
                to determine the effects of vitamin D supplementation on aspects of neuromuscular function known to be risk factors for falls and fractures.
                randomised, double-blind, placebo-controlled study.
                falls clinic taking referrals from general practitioners and accident and emergency department.
                139 ambulatory subjects (>/=65 years) with a history of falls and 25-hydroxyvitamin D (25OHD) </=12 microg/l. Intervention: patients were randomised to receive a single intramuscular injection of 600,000 i.u. ergocalciferol or placebo.
                assessments including biochemistry, postural sway, choice reaction time (CRT), aggregate functional performance time (AFPT), and quadriceps strength were carried out at baseline and 6 months post-intervention.
                baseline characteristics were comparable between both groups. 25OHD in the treatment group increased significantly at 6 months. AFPT deteriorated in the control group and improved in the intervention group, representing a significant difference between groups (+6.6 s versus -2.0 s, t = 2.80, P < 0.05). Similar changes were observed for CRT (-0.06 s versus +0.41 s, t = -2.52, P < 0.01) and postural sway (+0.0025 versus -0.0138, t = 2.35, P < 0.02). There was no significant difference in muscle strength change between groups (-10 N versus -2 N, t = -1.26, ns). A significant correlation between change in AFPT and change in 25OHD levels was observed (r = 0.19, P = 0.03). There was no significant difference in the number of falls (0.39 versus 0.24, t = 1.08, P = 0.28) or fallers (14 versus 11, P = 0.52) between two groups.
                vitamin D supplementation, in fallers with vitamin D insufficiency, has a significant beneficial effect on functional performance, reaction time and balance, but not muscle strength. This suggests that vitamin D supplementation improves neuromuscular or neuroprotective function, which may in part explain the mechanism whereby vitamin D reduces falls and fractures. To determine whether vitamin D supplementation reduces the risk of fracture or falls in elderly people in care home accommodation.
                A randomised controlled trial of cluster design.
                223 Residential units (mainly identical 30-bedded units), within 118 homes for elderly people throughout Britain, with 3,717 participating residents (76% women, average age 85 years). The units provided mainly or entirely residential care (35% of residents), nursing care (42%) or care for elderly mentally infirm (EMI) residents (23%).
                Participants were randomly allocated by residential unit (cluster design) to a treated group offered ergocalciferol 2.5 mg every 3 months (equivalent to a daily dose of 1,100 IU), or to a control group. Fractures were reported by staff and confirmed in hospital, and routinely collected data on reported falls were obtained.
                After median follow-up of 10 months (interquartile range 7-14 months), 64 (3.6%) of 1,762 vitamin D-treated residents and 51 (2.6%) of 1,955 controls had one or more non-vertebral fractures, and 24 (1.3%) and 20 (1.0%), respectively, had a hip fracture. The proportion reporting at least one fall was 44% in vitamin D-treated and 43% in control residents. The differences between the vitamin D and control groups were not statistically significant. The incidence of all non-vertebral fractures in the care homes (3.2% per year) and of hip fractures (1.1% per year) was low, similar to rates in elderly people in sheltered accommodation, and the pre-treatment serum 25-hydroxy vitamin D concentration was high [median 47 nmol/l, measured in a 1% (n = 18) sample].
                We found no evidence that vitamin D prevents fractures or falls in elderly people in care home accommodation. Vitamin D supplementation is suggested to reduce the risk of falls among ambulatory or institutionalized elderly subjects. The present study was undertaken to address the reduced risk of falls and hip fractures in patients with long-standing stroke by vitamin D supplementation.
                Ninety-six elderly women with poststroke hemiplegia were followed for two years. Patients were randomly assigned to one of the two groups, and 48 patients received 1,000 IU ergocalciferol daily, and the remaining 48 received placebo. The number of falls per person and incidence of hip fractures were compared between the two groups. Strength and tissue ATPase of skeletal muscles on the nonparetic side were assessed before and after the study.
                At baseline, serum 25-hydroxyvitamin D levels were in the deficient range (<10 ng/ml) in all patients; and vitamin D treatment enhanced serum 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D levels. Vitamin D treatment accounted for a 59% reduction in falls (95% CI, 28-81%; p = 0.003). There were increases in the relative number and size of type II muscle fibers and improved muscle strength in the vitamin D-treated group. Hip fractures occurred in 4 of 48 placebo group and 0 in 48 vitamin D2 group during the 2-year study period (log-rank, p = 0.049).
                Vitamin D may increase muscle strength by improving atrophy of type II muscle fibers, which may lead to decreased falls and hip fractures.
                Copyright (c) 2005 S. Karger AG, Basel. Osteoporotic fractures in older people are a major and increasing public health problem. We examined the effect of vitamin D supplementation on fracture rate in people living in sheltered accommodation.
                In a pragmatic double blind randomised controlled trial of 3 years duration, we examined 3,440 people (2,624 women and 816 men) living in residential or care home. We used four-monthly oral supplementation using 100,000 IU vitamin D(2) (ergocalciferol). As a main outcome measure, we used the incidence of first fracture using an intention to treat analysis. This was a multicentre study in 314 care homes or sheltered accommodation complexes in South Wales, UK.
                The vitamin D and placebo groups had similar baseline characteristics. In intention-to-treat analysis, 205 first fractures occurred in the intervention group during a total of 2,846 person years of follow-up (7 fractures per 100 people per year of follow-up), with 218 first fractures in the control group over 2,860 person years of follow-up. The hazard ratio of 0.95 (95% confidence interval 0.79-1.15) for intervention compared to control was not statistically significant.
                Supplementation with four-monthly 100,000 IU of oral vitamin D(2) is not sufficient to affect fracture incidence among older people living in institutional care. To assess the effectiveness of a multivitamin (MV) tablet on nutritional status, quantitative heel ultrasound (QUS), mobility, muscle strength and falls. The design comprised two groups matched on mobility levels, randomized to receive a daily MV or placebo (P) tablet for 6 months. The setting was an Australian residential care facility.
                A total of 92 aged care residents. Serum micronutrients, body weight, QUS, rate of falls, hand grip strength, and the timed up and go test were assessed at baseline and 6 months.
                A total of 49 participants consumed a MV and 43, a matched P for 6 months. There was a greater increase in the MV vs P group for serum 25(OH)D (mean difference+/-standard error, 33.4+/-2.6 nmol l(-1)), folate (13.4+/-2.8 nmol l(-1)), and vitamin B12 (178.0+/-40.3 pmol l(-1)) (all P<0.001). Adequate 25(OH)D concentrations (> or =50 nmol l(-1)) were found among 77% of participants in the MV group vs 10% taking P (P<0.001). Adjusting for baseline levels, the increase in QUS was greater in the MV vs P group (3.0+/-2.0 dB MHz(-1) vs -2.9+/-2.1 dB MHz(-1), respectively, P=0.041). There was a trend towards a 63% lower mean number of falls in the MV vs P group (0.3+/-0.1 falls vs 0.8+/-0.3 falls, P=0.078).
                MV supplementation raised serum vitamin B12 and folate concentrations and increased serum 25(OH)D, which was accompanied by an apparent positive effect on bone density. We also found a trend towards a reduction in falls and this could contribute to a reduction in fractures. Specific receptors for vitamin D have been identified in human muscle tissue. Cross-sectional studies show that elderly persons with higher vitamin D serum levels have increased muscle strength and a lower number of falls. We hypothesized that vitamin D and calcium supplementation would improve musculoskeletal function and decrease falls. In a double-blind randomized controlled trial, we studied 122 elderly women (mean age, 85.3 years; range, 63-99 years) in long-stay geriatric care. Participants received 1200 mg calcium plus 800 IU cholecalciferol (Cal+D-group; n = 62) or 1200 mg calcium (Cal-group; n = 60) per day over a 12-week treatment period. The number of falls per person (0, 1, 2-5, 6-7, >7 falls) was compared between the treatment groups. In an intention to treat analysis, a Poisson regression model was used to compare falls after controlling for age, number of falls in a 6-week pretreatment period, and baseline 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D serum concentrations. Among fallers in the treatment period, crude excessive fall rate (treatment - pretreatment falls) was compared between treatment groups. Change in musculoskeletal function (summed score of knee flexor and extensor strength, grip strength, and the timed up&go test) was measured as a secondary outcome. Among subjects in the Cal+D-group, there were significant increases in median serum 25-hydroxyvitamin D (+71%) and 1,25-dihydroxyvitamin D (+8%). Before treatment, mean observed number of falls per person per week was 0.059 in the Cal+D-group and 0.056 in the Cal-group. In the 12-week treatment period, mean number of falls per person per week was 0.034 in the Cal+D-group and 0.076 in the Cal-group. After adjustment, Cal+D-treatment accounted for a 49% reduction of falls (95% CI, 14-71%; p < 0.01) based on the fall categories stated above. Among fallers of the treatment period, the crude average number of excessive falls was significantly higher in the Cal-group (p = 0.045). Musculoskeletal function improved significantly in the Cal+D-group (p = 0.0094). A single intervention with vitamin D plus calcium over a 3-month period reduced the risk of falling by 49% compared with calcium alone. Over this short-term intervention, recurrent fallers seem to benefit most by the treatment. The impact of vitamin D on falls might be explained by the observed improvement in musculoskeletal function. A randomized double-blind controlled trial of the effect of vitamin D supplementation on the abilities of elderly hospital patients to carry out basic activities of daily life is described. Those patients included in the trial had plasma 25-hydroxyvitamin D concentrations which were low or low normal as judged by the normal range in young adults. After 2 to 9 months on the trial there was no significant difference in the performance of the control and treatment groups. To compare the effect of calcium/vitamin D supplements with a combination of calcium/vitamin D supplements and exercise/protein on risk of falling and postural balance.
                Randomized clinical trial.
                University hospital physiotherapy department.
                Twenty-four independently living elderly females aged 65 years and older with osteopenia or osteoporosis and mean total hip T-score (SD) of -1.8 (0.8).
                A three-month programme consisting of exercise/protein including training of muscular strength, co-ordination, balance and endurance. Calcium/ vitamin D was supplemented in all participants for a 12-month period.
                Assessment took place prior to and following the months 3, 6, 9 and at the end of the study; primary dependent variables assessed were risk of falling (Berg Balance Test) and postural balance (forceplate). Secondary measures included body composition, strength, activity level, number of falls, bone mineral content, biochemical indices, nutritional status and general health.
                Significant reductions of risk of falling (repeated measures ANOVA F = 8.90, P = 0.008), an increase in muscular strength (ANOVA F = 3.0, P = 0.03), and an increase in activity level (ANOVA F = 3.38, P = 0.02) were found in the experimental group as compared to the control group. Further on, there was 89% reduction of falls reported in the experimental group (experimental pre/post 8/1 falls; control group pre/post 5/6 falls).
                This study provides support for our intervention programme aimed at reducing the risk of falling in elderly participants diagnosed with osteopenia or osteoporosis. The data obtained from the pilot study allow the calculation of the actual sample size needed for a larger randomized trial. To test the effectiveness of using a full-time project nurse to assist residential aged care facilities in using evidence-based approaches to falls injury prevention.
                Cluster randomised controlled trial involving 5391 residents in 88 aged care facilities in the Hunter and Lower Mid North Coast areas of New South Wales. Residents were followed for 545 days or until death or discharge. Data were collected from July 2005 to June 2007.
                Employment of a project nurse to encourage best-practice falls injury prevention strategies during the 17-month intervention period.
                Monthly data about falls, falls injury and falls injury prevention programs; audit of hospitalisation for fractured neck of femur.
                Despite significant increases in the provision of hip protectors and use of vitamin D supplementation in both intervention and control facilities, there was no difference in the number of falls or falls injuries between the intervention and control groups, nor a reduction in falls overall. There was also no difference between the 7-month pre-intervention period and the intervention period in the number of falls or falls injuries. Factors related to residents having an increased risk of falls with fractured neck of femur included being ambulant, having dementia, increasing age, and having a high falls risk assessment score.
                It is difficult to change falls risk among high-risk populations, including people with dementia. The use of important strategies such as hip protectors and vitamin D and calcium supplementation increased during the study, probably with contamination of control facilities. Longer follow-up may be required to measure the impact on falls outcomes of the strategy of using a facilitating nurse.
                Australian New Zealand Clinical Trials Registry ACTRN12605000540617. In 242 community-dwelling seniors, supplementation with either 1000 mg of calcium or 1000 mg of calcium plus vitamin D resulted in a decrease in the number of subjects with first falls of 27% at month 12 and 39% at month 20. Additionally, parameters of muscle function improved significantly.
                The efficacy of vitamin D and calcium supplementation on risk of falling in the elderly is discussed controversially. Randomized controlled trials using falls as primary outcome are needed. We investigated long-term effects of calcium and vitamin D on falls and parameters of muscle function in community-dwelling elderly women and men.
                Our study population consisted of 242 individuals recruited by advertisements and mailing lists (mean [ +/- SD] age, 77 +/- 4 years). All serum 25-hydroxyvitamin D (25[OH]D) levels were below 78 nmol/l. Individuals received in a double blinded fashion either 1000 mg of calcium or 1000 mg of calcium plus 800 IU of vitamin D per day over a treatment period of 12 months, which was followed by a treatment-free but still blinded observation period of 8 months. Falls were documented using diaries. The study took place in Bad Pyrmont, Germany (latitude 52 degrees ) and Graz, Austria (latitude 46 degrees ).
                Compared to calcium mono, supplementation with calcium plus vitamin D resulted in a significant decrease in the number of subjects with first falls of 27% at month 12 (RR = 0.73; CI = 0.54-0.96) and 39% at month 20 (RR = 0.61; CI = 0.34-0.76). Concerning secondary endpoints, we observed significant improvements in quadriceps strength of 8%, a decrease in body sway of 28%, and a decrease in time needed to perform the TUG test of 11%.
                Combined calcium and vitamin D supplementation proved superior to calcium alone in reducing the number of falls and improving muscle function in community-dwelling older individuals. To assess the effectiveness of a targeted, multiple intervention falls prevention programme in reducing falls and injuries related to falls in a subacute hospital.
                Randomised controlled trial of a targeted multiple intervention programme implemented in addition to usual care compared with usual care alone.
                Three subacute wards in a metropolitan hospital specialising in rehabilitation and care of elderly patients.
                626 men and women aged 38 to 99 years (average 80 years) were recruited from consecutive admissions to subacute hospital wards.
                Falls risk alert card with information brochure, exercise programme, education programme, and hip protectors.
                Incidence rate of falls, injuries related to falls, and proportion of participants who experienced one or more falls during their stay in hospital.
                Participants in the intervention group (n = 310) experienced 30% fewer falls than participants in the control group (n = 316). This difference was significant (Peto log rank test P = 0.045) and was most obvious after 45 days of observation. In the intervention group there was a trend for a reduction in the proportion of participants who experienced falls (relative risk 0.78, 95% confidence interval 0.56 to 1.06) and 28% fewer falls resulted in injury (log rank test P = 0.20).
                A targeted multiple intervention falls prevention programme reduces the incidence of falls in the subacute hospital setting. To assess the efficacy and cost effectiveness of a home safety programme and a home exercise programme to reduce falls and injuries in older people with low vision.
                Randomised controlled trial.
                Dunedin and Auckland, New Zealand.
                391 women and men aged > or =75 with visual acuity of 6/24 or worse who were living in the community; 92% (361 of 391) completed one year of follow-up.
                Participants received a home safety assessment and modification programme delivered by an occupational therapist (n = 100), an exercise programme prescribed at home by a physiotherapist plus vitamin D supplementation (n = 97), both interventions (n = 98), or social visits (n = 96).
                Numbers of falls and injuries resulting from falls, costs of implementing the home safety programme.
                Fewer falls occurred in the group randomised to the home safety programme but not in the exercise programme (incidence rate ratios 0.59 (95% confidence interval 0.42 to 0.83) and 1.15 (0.82 to 1.61), respectively). However, within the exercise programme, stricter adherence was associated with fewer falls (P = 0.001). A conservative analysis showed neither intervention was effective in reducing injuries from falls. Delivering the home safety programme cost NZ650 dollars (234 pounds sterling, 344 euros, US432 dollars) (at 2004 prices) per fall prevented.
                The home safety programme reduced falls and was more cost effective than an exercise programme in this group of elderly people with poor vision. The Otago exercise programme with vitamin D supplementation was not effective in reducing falls or injuries in this group, possibly due to low levels of adherence. Trial registration number ISRCTN15342873. Randomized controlled trials have shown that a combination of vitamin D and calcium can prevent fragility fractures in the elderly. Whether this effect is attributed to the combination of vitamin D and calcium or to one of these nutrients alone is not known. We studied if an intervention with 10 microg of vitamin D3 per day could prevent hip fracture and other osteoporotic fractures in a double-blinded randomized controlled trial. Residents from 51 nursing homes were allocated randomly to receive 5 ml of ordinary cod liver oil (n = 569) or 5 ml of cod liver oil where vitamin D was removed (n = 575). During the study period of 2 years, fractures and deaths were registered, and the principal analysis was performed on the intention-to-treat basis. Biochemical markers were measured at baseline and after 1 year in a subsample. Forty-seven persons in the control group and 50 persons in the vitamin D group suffered a hip fracture. The corresponding figures for all nonvertebral fractures were 76 persons (control group) and 69 persons (vitamin D group). There was no difference in the incidence of hip fracture (p = 0.66, log-rank test), or in the incidence of all nonvertebral fractures (p = 0.60, log-rank test) in the vitamin D group compared with the control group. Compared with the control group, persons in the vitamin D group increased their serum 25-hydroxyvitamin D concentration with 22 nmol/liter (p = 0.001). In conclusion, we found that an intervention with 10 microg of vitamin D3 alone produced no fracture-preventing effect in a nursing home population of frail elderly people. The hypothesis was that the calcium and vitamin D supplementation prevents falls at the population level.Study design: The OSTPRE-FPS was a randomized population-based open-trial with 3-year follow-up. The supplementation group (n=1566) received daily cholecalciferol 800IU+calcium carbonate 1000mg, while the control group (n=1573) received no supplementation or placebo. A randomly selected subsample of 593 subjects underwent a detailed measurement program including serum 25(OH)D measurements.
                The occurrence of falls was the primary outcome of the study. The participants in the subsample were telephoned at 4 months intervals and the rest of the trial population was interviewed by phone once a year.
                In the entire trial population (ETP), there were 812 women with 1832 falls in the intervention group and 833 women with 1944 falls in the control group (risk ratio was 0.98, 95% CI 0.92-1.05, P=0.160). The supplementation was not associated with single or multiple falls in the ETP. However, in the subsample, multiple fall incidence decreased by 30% (odds ratio (OR) 0.70, 95% CI 0.50-0.97, P=0.034) in the supplementation group. Further, the supplementation decreased the incidence of multiple falls requiring medical attention (OR 0.72, 95% CI 0.53-0.97, P=0.031) in the ETP. The mean compliance in the entire trial population was 78% and in the subsample 79%.
                Overall, the primary analysis showed no association between calcium and vitamin D supplementation and risk of falls. However, the results of a post hoc analysis suggested that there was a decreased risk of multiple falls requiring medical attention: this finding requires confirmation.
                Copyright 2009 Elsevier Ireland Ltd. All rights reserved. to determine the clinical effectiveness of a day hospital-delivered multifactorial falls prevention programme, for community-dwelling older people at high risk of future falls identified through a screening process.
                multicentre randomised controlled trial.
                eight general practices and three day hospitals based in the East Midlands, UK. Participants: three hundred and sixty-four participants, mean age 79 years, with a median of three falls risk factors per person at baseline. Interventions: a day hospital-delivered multifactorial falls prevention programme, consisting of strength and balance training, a medical review and a home hazards assessment. Main outcome measure: rate of falls over 12 months of follow-up, recorded using self-completed monthly diaries.
                one hundred and seventy-two participants in each arm contributed to the primary outcome analysis. The overall falls rate during follow-up was 1.7 falls per person-year in the intervention arm compared with 2.0 falls per person-year in the control arm. The stratum-adjusted incidence rate ratio was 0.86 (95% CI 0.73-1.01), P = 0.08, and 0.73 (95% CI 0.51-1.03), P = 0.07 when adjusted for baseline characteristics. There were no significant differences between the intervention and control arms in any secondary outcomes.
                this trial did not conclusively demonstrate the benefit of a day hospital-delivered multifactorial falls prevention programme, in a population of older people identified as being at high risk of a future fall. survivors of hip fracture are at 5- to 10-fold risk of a second hip fracture. There is little consensus about secondary prevention. Many are given calcium and vitamin D, but the evidence supporting this is circumstantial.
                to compare the effects of different calcium and vitamin D supplementation regimens on bone biochemical markers, bone mineral density and rate of falls in elderly women post-hip fracture.
                randomised controlled trial.
                orthogeriatric rehabilitation ward.
                150 previously independent elderly women, recruited following surgery for hip fracture, were assigned to receive a single injection of 300,000 units of vitamin D(2), injected vitamin D(2) plus 1 g/day oral calcium, 800 units/day oral vitamin D(3) plus 1 g/day calcium, or no treatment. Follow-up was one year, with measurement of 25-hydroxyvitamin D, parathyroid hormone, bone mineral density, and falls.
                mean 25-hydroxyvitamin D increased and mean parathyroid hormone was suppressed in all the actively treated groups, more so in the group receiving combined oral vitamin D and calcium. Twenty per cent of participants injected with vitamin D were deficient in 25-hydroxyvitamin D a year later. Bone mineral density showed small but statistically significant differences of up to 4.6% between actively treated groups and placebo. Relative risk of falling in the groups supplemented with vitamin D was 0.48 (95% CI 0.26-0.90) compared with controls.
                Vitamin D supplementation, either orally or with injected vitamin D, suppresses parathyroid hormone, increases bone mineral density and reduces falls. Effects may be more marked with calcium co-supplementation. The 300,000 units of injected vitamin D may not last a whole year. To determine whether the oral nutritional supplementation of undernourished older people upon discharge from hospital improves muscle function and reduces disability.
                Randomized controlled trial.
                Community-based study in two centers in Scotland.
                Two hundred fifty-three people.
                Randomization to oral nutritional supplementation (600 kcal/d) or control supplement of 200 kcal/d.
                Primary outcome (20-point activity of daily living Barthel Index) and secondary outcomes (handgrip strength, Sit-to-Stand test, and Euroquol) were measured at baseline (after discharge from the hospital and before supplement was commenced) and 8 and 16 weeks and accelerometry-measured physical activity levels at baseline and 16 weeks. Falls were recorded prospectively.
                Mean age was 82. There was no significant difference in change in Barthel score between supplement and control groups (adjusted mean difference=0.28, 95% confidence interval (CI)=-0.28-0.84). Handgrip strength improved more in the supplemented group (adjusted mean difference=1.52 kg, 95% CI=0.50-2.55; P=.004). The supplemented group exhibited modestly greater vector movement (overall activity) than controls (P=.02). There were no significant between-group differences in Sit-to-Stand test, health-related quality of life, or falls. Adherence was 38.2% in the nutritional supplement group and 50.0% in the control supplement group. Weight did not increase in the nutritional supplement group as a whole, but on-treatment analysis adjusting for adherence showed a mean weight gain of 1.17 kg (95% CI=0.07-2.27; P=.04) more than in controls.
                Oral nutritional supplementation of undernourished older people upon hospital discharge did not reduce disability, despite improving handgrip strength and modestly increasing objectively measured physical activity levels. Lack of an effect of the nutritional supplement used in this study may have been due to low adherence, suggesting that different approaches to nutritional supplementation need to be tested in this population. Improving vitamin D status may be an important modifiable risk factor to reduce falls and fractures; however, adherence to daily supplementation is typically poor.
                To determine whether a single annual dose of 500,000 IU of cholecalciferol administered orally to older women in autumn or winter would improve adherence and reduce the risk of falls and fracture.
                A double-blind, placebo-controlled trial of 2256 community-dwelling women, aged 70 years or older, considered to be at high risk of fracture were recruited from June 2003 to June 2005 and were randomly assigned to receive cholecalciferol or placebo each autumn to winter for 3 to 5 years. The study concluded in 2008.
                500,000 IU of cholecalciferol or placebo.
                Falls and fractures were ascertained using monthly calendars; details were confirmed by telephone interview. Fractures were radiologically confirmed. In a substudy, 137 randomly selected participants underwent serial blood sampling for 25-hydroxycholecalciferol and parathyroid hormone levels.
                Women in the cholecalciferol (vitamin D) group had 171 fractures vs 135 in the placebo group; 837 women in the vitamin D group fell 2892 times (rate, 83.4 per 100 person-years) while 769 women in the placebo group fell 2512 times (rate, 72.7 per 100 person-years; incidence rate ratio [RR], 1.15; 95% confidence interval [CI], 1.02-1.30; P = .03). The incidence RR for fracture in the vitamin D group was 1.26 (95% CI, 1.00-1.59; P = .047) vs the placebo group (rates per 100 person-years, 4.9 vitamin D vs 3.9 placebo). A temporal pattern was observed in a post hoc analysis of falls. The incidence RR of falling in the vitamin D group vs the placebo group was 1.31 in the first 3 months after dosing and 1.13 during the following 9 months (test for homogeneity; P = .02). In the substudy, the median baseline serum 25-hydroxycholecalciferol was 49 nmol/L. Less than 3% of the substudy participants had 25-hydroxycholecalciferol levels lower than 25 nmol/L. In the vitamin D group, 25-hydroxycholecalciferol levels increased at 1 month after dosing to approximately 120 nmol/L, were approximately 90 nmol/L at 3 months, and remained higher than the placebo group 12 months after dosing.
                Among older community-dwelling women, annual oral administration of high-dose cholecalciferol resulted in an increased risk of falls and fractures.
                anzctr.org.au Identifier: ACTRN12605000658617; isrctn.org Identifier: ISRCTN83409867. To determine the efficacy of a targeted multifactorial falls prevention programme in elderly care wards with relatively short lengths of stay.
                Cluster randomised trial.
                24 elderly care wards in 12 hospitals in Sydney, Australia.
                3999 patients, mean age 79 years, with a median hospital stay of seven days.
                A nurse and physiotherapist each worked for 25 hours a week for three months in all intervention wards. They provided a targeted multifactorial intervention that included a risk assessment of falls, staff and patient education, drug review, modification of bedside and ward environments, an exercise programme, and alarms for selected patients.
                Falls during hospital stay.
                Intervention and control wards were similar at baseline for previous rates of falls and individual patient characteristics. Overall, 381 falls occurred during the study. No difference was found in fall rates during follow-up between intervention and control wards: respectively, 9.26 falls per 1000 bed days and 9.20 falls per 1000 bed days (P=0.96). The incidence rate ratio adjusted for individual lengths of stay and previous fall rates in the ward was 0.96 (95% confidence interval 0.72 to 1.28).
                A targeted multifactorial falls prevention programme was not effective among older people in hospital wards with relatively short lengths of stay.
                Australian New Zealand Clinical Trials Registry ACTRNO 12605000467639. To assess whether a pragmatic multidisciplinary fall-prevention program was more effective than usual care in preventing new falls and functional decline in elderly people.
                A two-group, randomized, controlled trial with 12 months of follow-up.
                University hospital and home-based intervention, the Netherlands.
                Three hundred thirty-three community-dwelling Dutch people aged 65 and over who were seen in an emergency department after a fall.
                Participants in the intervention group underwent a detailed medical and occupational-therapy assessment to evaluate and address risk factors for recurrent falls, followed by recommendations and referral if indicated. People in the control group received usual care.
                Number of people sustaining a fall (fall calendar) and daily functioning (Frenchay Activity Index).
                Results showed no statistically significantly favorable effects on falls (odds ratio=0.86, 95% confidence interval (CI)=0.50-1.49) or daily functioning (regression coefficient=0.37, CI=-0.90 to 1.63) after 12 months of follow-up.
                The multidisciplinary fall-prevention program was not effective in preventing falls and functional decline in this Dutch healthcare setting. Implementing the program in its present form in the Netherlands is not recommended. This trial shows that there can be considerable discrepancy between the "ideal" (experimental) version of a program and the implemented version of the same program. The importance of implementation research in assessing feasibility and effectiveness of such a program in a specific healthcare setting is therefore stressed. Sunlight exposure by improving vitamin D status could be a simple public health strategy in reducing falls among frail elder people. In a randomised controlled trial, adherence to sunlight exposure was low (median adherence, 26%) and no effect of increased UV exposure on falls risk was observed (incidence rate ratio (IRR) 1.06, P = 0.73).
                This study aimed to determine whether increased sunlight exposure was effective to improve vitamin D status and reduce falls in the elderly.
                In a cluster randomised controlled trial (NCT00322166 at ClinicalTrials.gov), 602 residents aged 70 or more (mean age, 86.4 years; 71% female) were recruited from 51 aged care facilities in Northern Sydney, Australia. Participants were randomised by facility to receive either increased sunlight exposure (additional 30-40 min/day in the early morning) with (UV+) or without (UV) calcium supplementation (600 mg/day) or neither (control) for a year. The co-primary endpoints were change in serum 25 hydroxy vitamin D (25OHD) and falls incidence after 12 months.
                Adherence to sunlight exposure was low (median adherence, 26%; IQR, 7%-45%). Serum 25OHD levels were low at baseline (median, 32.9 nmol/L) and increased only slightly depending on the number of sunlight sessions attended over 12 months (P = 0.04). During the study, 327 falls occurred in 111 (54%) subjects in the control group, 326 falls in 111 (58%) subjects in the UV only group and 335 falls in 108 (52%) subjects in the UV+ group. By intention-to-treat analysis, there was no significant effect of increased UV exposure on falls risk (IRR, 1.06; 95% CI, 0.76-1.48; P = 0.73). However, in 66 participants who attended ≥130 sessions per year (adherence, ≥50% of 260 sessions-five per week), falls were significantly reduced (IRR, 0.52; 95% CI, 0.31-0.88; P = 0.01) compared with the control group.
                Increased sunlight exposure did not reduce vitamin D deficiency or falls risk in frail older people. This public health strategy was not effective most likely due to poor adherence to the intervention. Falls and resulting injuries are particularly common in older people living in residential care facilities, but knowledge about the prevention of falls is limited.
                To investigate whether a multifactorial intervention program would reduce falls and fall-related injuries.
                A cluster randomized, controlled, nonblinded trial.
                9 residential care facilities located in a northern Swedish city.
                439 residents 65 years of age or older.
                An 11-week multidisciplinary program that included both general and resident-specific, tailored strategies. The strategies comprised educating staff, modifying the environment, implementing exercise programs, supplying and repairing aids, reviewing drug regimens, providing free hip protectors, having post-fall problem-solving conferences, and guiding staff.
                The primary outcomes were the number of residents sustaining a fall, the number of falls, and the time to occurrence of the first fall. A secondary outcome was the number of injuries resulting from falls.
                During the 34-week follow-up period, 82 residents (44%) in the intervention program sustained a fall compared with 109 residents (56%) in the control group (risk ratio, 0.78 [95% CI, 0.64 to 0.96]). The adjusted odds ratio was 0.49 (CI, 0.37 to 0.65), and the adjusted incidence rate ratio of falls was 0.60 (CI, 0.50 to 0.73). Each of 3 residents in the intervention group and 12 in the control group had 1 femoral fracture (adjusted odds ratio, 0.23 [CI, 0.06 to 0.94]). Clustering was considered in all regression models.
                An interdisciplinary and multifactorial prevention program targeting residents, staff, and the environment may reduce falls and femoral fractures. To determine whether vitamin D supplementation decreases the incidence of hip fractures and other peripheral bone fractures.
                Prospective, double-blind trial.
                Community setting (Amsterdam and surrounding area).
                2578 persons (1916 women, 662 men) 70 years of age and older (mean age +/- SD, 80 +/- 6 years) living independently, in apartments for elderly persons, or in homes for elderly persons.
                Participants were randomly assigned to receive either vitamin D3, 400 IU in one tablet daily, or placebo for a maximum of 3.5 years.
                Dietary calcium intake and serum 25-hydroxyvitamin D [25(OH)D] were estimated in a subset of participants. During follow-up, attention was concentrated on hip fractures and other peripheral fractures. The maximal follow-up period was 4 years. The results were evaluated by survival analysis.
                Mean dietary calcium intake from dairy products was 868 mg/d. Mean serum 25(OH)D concentration in the third year of the study was 23 nmol/L in the placebo group and 60 nmol/L in the vitamin D group. Median follow-up was 3.5 years, and total follow-up was 8450 patient-years. During follow-up, 306 persons in the placebo group and 282 persons in the vitamin D group died (P = 0.20). Hip fractures occurred in 48 persons in the placebo group and 58 persons in the vitamin D group (P = 0.39, intention-to-treat analysis). Other peripheral fractures occurred in 74 persons in the placebo group and 77 persons in the vitamin D group (P = 0.86).
                Our results do not show a decrease in the incidence of hip fractures and other peripheral fractures in Dutch elderly persons after vitamin D supplementation. This article is a report of a randomized controlled trial to examine the effectiveness of a targeted multiple intervention strategy in reducing the number of patient falls in an acute care hospital.
                Prevention of patient falls remains a challenge that has eluded healthcare institutions. The effectiveness of targeted multiple fall prevention interventions in reducing the incidences of falling has not been established.
                Patients who scored 5 and above on the Hendrich II Fall Risk Model, a fall assessment tool, were recruited in 2006. Patients who were randomized to the intervention group received targeted multiple interventions. Both the research groups received the standard fall prevention interventions from the ward nurses. The rates of fall incidences for both groups were reported with 95% CI, calculated using Wilson method and compared using the Chi-square test. The relative risk was estimated and 95% CI was calculated using the methods described by Armitage and Berry. The times to first fall events were constructed using the Kaplan-Meier method. The hazard ratio was reported at 95% CI and the comparison was made using the log-rank test.
                There were 912 and 910 participants in the control and intervention groups, respectively. The fall incidence rates were 1·5% (95% CI: 0·9-2·6) and 0·4% (95% CI: 0·2-1·1) in the control and intervention groups, respectively. The relative risk estimate of 0·29 (95% CI: 0·1-0·87) favours the intervention group.
                This study showed that targeted multiple interventions were effective in reducing the incidences of falls in patients in the acute care setting.
                © 2011 Blackwell Publishing Ltd. Many patients admitted to acute hospital services are underweight or harbour vitamin deficiencies.
                To determine the effect on patient throughput of a policy of routine vitamin supplementation, and of early routine sipfeed supplementation in 'thin' patients (5-10% weight loss or body mass index 18-22).
                Factorial randomized placebo controlled trial of oral multivitamins from the first day of admission, and, after nutritional screening, of a nutritionally complete sipfeed from the second day in 'thin' patients.
                Acute medical, surgical and orthopaedic hospital services of a London teaching hospital.
                1561 patients admitted as emergencies were included in the vitamin study of which 549 were included in the sipfeed study.
                Length of hospital stay (LOS).
                Offering multivitamins to acute admissions resulted in a mean change (reduction) in LOS of -0.4 days 95% CI (-2-1.2days). The results suggest greater reductions for those discharged after 10 days: mean change=-2.3 days 95% CI (-5.7 to 1.2). Sipfeed supplementation was associated with an increased mean length of stay 2.8 days 95% CI (-0.8-6.3). 18% of acute admissions were classified undernourished on the basis of BMI, MUAC or percent weight loss combined.
                No benefit was observed for sipfeed intervention although a small benefit of less than one day is not excluded. Vitamin supplementation may have slight but economically important benefit.
                Copyright 2001 Harcourt Publishers Ltd. Falls occur frequently in older people and strongly affect quality of life. Guidelines recommend multifactorial, targeted fall prevention. We evaluated the effectiveness of a multifactorial intervention in older persons with a high risk of recurrent falls.
                A randomized controlled trial was conducted from April 3, 2005, to July 21, 2008, at the geriatric outpatient clinic of a university hospital and regional general practices in the Netherlands. Of 2015 persons identified, 217 persons aged 65 years or older were selected to participate. They had a high risk of recurrent falls and no cognitive impairment and had visited the emergency department or their family physician after a fall. The geriatric assessment and intervention were aimed at reduction of fall risk factors. Primary outcome measures were time to first and second falls after randomization. Secondary outcome measures were fractures, activities of daily living, quality of life, and physical performance.
                Within 1 year, 55 (51.9%) of the 106 intervention participants and 62 (55.9%) of the 111 usual care (control) participants fell at least once. No significant treatment effect was demonstrated for the time to first fall (hazard ratio, 0.96; 95% confidence interval, 0.67-1.37) or the time to second fall (1.13; 0.71-1.80). Similar results were obtained for secondary outcome measures and for per-protocol analysis. One intervention participant died vs 7 in the control group (hazard ratio, 0.15; 95% confidence interval, 0.02-1.21).
                This multifactorial fall-prevention program does not reduce falls in high-risk, cognitively intact older persons. Trial Registration isrctn.org Identifier: ISRCTN11546541. Low trauma fractures in older people incur enormous physical, social and economic costs. Previous research indicates that an annual intramuscular injection of vitamin D may reduce fracture rates in this group. This strategy requires validation in a population setting.
                Randomized, double-blind, placebo-controlled trial of 300,000 IU intramuscular (i.m.) vitamin D2 (ergocalciferol) injection or matching placebo every autumn over 3 years. 9440 people (4354 men and 5086 women) aged 75 yrs and over were recruited from general practice registers in Wessex, England. Primary outcome measure was all non-vertebral fracture. Secondary outcomes were hip and wrist fractures, and all falls.
                585 subjects had incident non-spine fractures (hip 110, wrist 116, ankle 37). Hazard ratios (HRs) for fracture in the vitamin D group were: 1.09 [95% confidence interval (CI) 0.93-1.28, P = 0.29] for any first fracture, 1.49 (95% CI 1.02-2.18, P = 0.04) for hip and 1.22 (95% CI 0.85-1.76, P = 0.28) for wrist. There was no effect on falls: HR 0.98 (0.93-1.04). No protective effect was observed in any subgroup when the cohort was stratified by sex, age, previous fracture or mobility.
                An annual i.m. injection of 300,000 IU vitamin D2 is not effective in preventing non-vertebral fractures among elderly men and women resident in the general population. This study of 9605 community-dwelling residents supports that vitamin D and calcium supplementation may prevent osteoporotic fractures in elderly in a northern European region known to be deficient in vitamin D, especially during winter periods.
                We evaluated the effect of two programs for the prevention of osteoporotic fractures leading to acute hospital admission in a population of elderly community-dwelling residents.
                This was a factorial, cluster-randomized, pragmatic, intervention study. We included 9605 community-dwelling residents aged 66+ years. We offered a prevention program of a daily supplement of 1000 mg of elemental calcium as calcium carbonate and 400 IU (10 microg) of vitamin D3 to a total of 4957 participants. Another program with evaluation and suggestions for the improvement of the domestic environment was offered to a total of 5063 participants. Both programs included revision of the resident's current pharmaceutical treatment. We achieved information on osteoporotic fractures in the study population from the Danish Hospital Registration Database. We defined osteoporotic fractures as low energy fractures of the proximal humerus, distal forearm, vertebral column, pelvis, cervical femur, and intertrochanteric femur.
                Active participation was 50.3% in the Calcium and Vitamin D Program and 46.4% in the Environmental and Health Program. We observed a 16% reduction in fracture incidence rate (relative risk [RR], 0.84; CI, 0.72-0.98; p < 0.025) among male and female residents offered the Calcium and Vitamin D Program (intention-to-prevent analysis).
                This study supports that vitamin D and calcium supplementation may prevent osteoporotic fractures in community-dwelling elderly people in a northern European region known to be deficient in vitamin D, especially during winter periods. Low 25-hydroxyvitamin D levels, commonly found in older patients with heart failure, may contribute to the chronic inflammation and skeletal myopathy that lead to poor exercise tolerance. We tested whether vitamin D supplementation of patients with heart failure and vitamin D insufficiency can improve physical function and quality of life.
                In a randomized, parallel group, double-blind, placebo-controlled trial, patients with systolic heart failure aged >or=70 years with 25-hydroxyvitamin D levels <50 nmol/L (20 ng/mL) received 100,000 U of oral vitamin D2 or placebo at baseline and 10 weeks. Outcomes measured at baseline, 10 weeks, and 20 weeks were 6-minute walk distance, quality of life (Minnesota score), daily activity measured by accelerometry, Functional Limitations Profile, B-type natriuretic peptide, and tumor necrosis factor-alpha. Participants in the vitamin D group had an increase in their 25-hydroxyvitamin D levels compared with placebo at 10 weeks (22.9 versus 2.3 nmol/L [9.2 versus 0.9 ng/mL]; P<0.001) and maintained this increase at 20 weeks. The 6-minute walk did not improve in the treatment group relative to placebo. No significant benefit was seen on timed up and go testing, subjective measures of function, daily activity, or tumor necrosis factor. Quality of life worsened by a small, but significant amount in the treatment group relative to placebo. B-type natriuretic peptide decreased in the treatment group relative to placebo (-22 versus +78 pg/mL at 10 weeks; P=0.04).
                Vitamin D supplementation did not improve functional capacity or quality of life in older patients with heart failure with vitamin D insufficiency. Clinical Trial Registration- www.controlled-trials.com. Identifier: ISRCTN51372896. The effect of vitamin D supplementation on bone mineral augmentation in 212 adolescent girls with adequate calcium intake was studied in a randomized placebo-controlled setting. Bone mineral augmentation determined by DXA increased with supplementation both in the femur and the lumbar vertebrae in a dose-responsive manner. Supplementation decreased the urinary excretion of resorption markers, but had no impact on formation markers.
                Adequate vitamin D intake protects the elderly against osteoporosis, but there exists no indisputable evidence that vitamin D supplementation would benefit bone mineral augmentation. The aim of this 1-year study was to determine in a randomized double-blinded trial the effect of 5 and 10 microg vitamin D3 supplementation on bone mineral augmentation in adolescent girls with adequate dietary calcium intake.
                Altogether, 228 girls (mean age, 11.4 +/- 0.4 years) participated. Their BMC was measured by DXA from the femur and lumbar spine. Serum 25-hydroxyvitamin D [S-25(OH)D], intact PTH (S-iPTH), osteocalcin (S-OC), and urinary pyridinoline (U-Pyr) and deoxypyridinoline (U-Dpyr) were measured. Statistical analysis was performed both with the intention-to-treat (IT) and compliance-based (CB) method.
                In the CB analysis, vitamin D supplementation increased femoral BMC augmentation by 14.3% with 5 microg and by 17.2% with 10 microg compared with the placebo group (ANCOVA, p = 0.012). A dose-response effect was observed in the vertebrae (ANCOVA, p = 0.039), although only with the highest dose. The mean concentration of S-25(OH)D increased (p < 0.001) in the 5-microg group by 5.7 +/- 15.7 nM and in the 10-microg group by 12.4 +/- 13.7 nM, whereas it decreased by 6.7 +/- 11.3 nM in the placebo group. Supplementation had no effect on S-iPTH or S-OC, but it decreased U-DPyr (p = 0.042).
                Bone mineral augmentation in the femur was 14.3% and 17.2% higher in the groups receiving 5 and 10 microg of vitamin D, respectively, compared with the placebo group, but only 10 mug increased lumbar spine BMC augmentation significantly. Vitamin D supplementation decreased the concentration of bone resorption markers, but had no impact on bone formation markers, thus explaining increased bone mineral augmentation. However, the positive effects were noted with the CB method but not with IT. To assess whether supplementation with calcium and cholecaliferol (vitamin D3) reduces the risk of fracture in women with one or more risk factors for fracture of the hip.
                Pragmatic open randomised controlled trial.
                Practice nurse led clinics in primary care.
                3314 women aged 70 and over with one or more risk factors for hip fracture: any previous fracture, low body weight (< 58 kg), smoker, family history of hip fracture, or fair or poor self reported health.
                Daily oral supplementation using 1000 mg calcium with 800 IU cholecaliferol and information leaflet on dietary calcium intake and prevention of falls, or leaflet only (control group).
                Primary outcome measure was all clinical fractures and secondary outcome measures were adherence to treatment, falls, and quality of life (measured with the SF-12).
                69% of the women who completed the follow-up questionnaire at 24 months were still taking supplements (55% with inclusion of randomised participants known to be alive). After a median follow-up of 25 months (range 18 to 42 months), clinical fracture rates were lower than expected in both groups but did not significantly differ for all clinical fractures (odds ratio for fracture in supplemented group 1.01, 95% confidence interval 0.71 to 1.43). The odds ratio for hip fracture was 0.75 (0.31 to 1.78). The odds of a woman having a fall at six and 12 months was 0.99 and 0.98, respectively. Quality of life did not significantly differ between the groups.
                We found no evidence that calcium and vitamin D supplementation reduces the risk of clinical fractures in women with one or more risk factors for hip fracture. Registration ISRCTN26118436, controlled trials registry. We investigated whether vitamin A supplementation would decrease mortality and morbidity rates in children infected with the human immunodeficiency virus (HIV).
                We conducted a randomized, double-blind, placebo-controlled clinical trial at Mulago Hospital, a large hospital that serves the urban and semiurban populations of Kampala, Uganda. One hundred eighty-one HIV-infected children were enrolled at 6 mo and randomized to receive vitamin A supplementation, 60 mg retinol equivalent, or placebo every 3 mo from ages 15 to 36 mo. Morbidity was assessed through a 7-d morbidity history every 3 mo, and vital events were measured. Children received daily trimethoprim-sulfamethoxazole prophylactic therapy.
                After age 15 mo, children were followed for a median of 17.8 mo (interquartile range = 11.1 to 21.0 mo). The trial was stopped when there was a new policy to implement a program of mass supplementation of vitamin A in the country. Mortality rates among 87 children in the vitamin A group and 94 children in the control group were 20.6% and 32.9%, respectively, yielding a relative risk of 0.54 (95% confidence interval, 0.30 to 0.98; P = 0.044) after adjusting for baseline weight-for-height Z score. Children who received vitamin A had lower modified point prevalences of persistent cough (odds ratio, 0.47; 95% confidence interval, 0.23 to 0.96; P = 0.038) and chronic diarrhea (odds ratio, 0.48; 95% confidence interval, 0.19 to 1.18; P = 0.11) and a shorter duration of ear discharge (P = 0.03). Vitamin A supplementation had no significant effect on modified point prevalences of fever, ear discharge, bloody stools, or hospitalizations.
                Vitamin A supplementation decreases mortality rate in HIV-infected children and should be considered in the care for these children in developing countries. To compare the effect of two modes of delivering a falls prevention service in reducing the rate of falls and improving quality of life, activity levels, and physical status among older adults with a history of recent falls.
                A randomized controlled trial was conducted with a total of 107 participants with blinded baseline and follow-up assessments. The participants were older community-dwelling adults referred for a falls prevention service located in Brisbane, Australia. The intervention was a multiple component falls prevention service delivered in either in a domiciliary or center-based mode of delivery. Both programs were similar apart from setting and consisted of three components, a balance and strength component, falls prevention education, and functional tasks. Physical and psychosocial assessments were administered at baseline, 8-week follow-up and 6-month follow-up. Falls data were collected by monthly telephone contact and by interview at 8 weeks and 6 months.
                The center-based service demonstrated significantly better results in preventing falls over the home-based service. Clients in the center-based arm of the trial experienced fewer total falls and this group also had a greater reduction in the total number of fallers after the intervention.
                This research demonstrates that delivering a similar service in different settings-home based or center based-impacts upon the effectiveness of the service. Community-dwelling older adults with a history of falls should be provided with center-based programs in preference to home-based programs where they are available. Vitamin A deficiency and acute lower respiratory tract infections coexist as important public health problems in many developing countries. We carried out a randomized, double-blind, placebo-controlled trial to examine whether large doses of vitamin A given to Tanzanian children who are admitted to the hospital with nonmeasles pneumonia would reduce the severity of respiratory disease. Six hundred eighty-seven children were randomly assigned to receive either placebo or vitamin A [200 000 IU (60 mg retinol equivalents) for children > 1 y of age and 100000 IU (30 mg retinol equivalents) for infants] on the day of admission and another dose on the following day. Of the 346 children in the vitamin A group, 13 died in the hospital, compared with 8 of 341 children in the placebo group; the relative mortality was 1.63 (95% CI: 0.67, 3.97; P = 0.28). The mean number of days of hospitalization was the same in both groups (4.2 d). There were no differences between the vitamin A and placebo groups in the duration of hospital stay when examined within categories of children stratified by age, sex, breast-feeding status, nutritional status at baseline, or quartile of dietary vitamin A intake in the 4 mo before admission to the hospital. There were also no differences in the mean number of days of fever, rapid respiratory rate, or hypoxia, whether these endpoints were examined in the total number of subjects or in a subset with more severe clinical conditions at baseline. Large doses of vitamin A had no protective effect on the course of pneumonia in hospitalized Tanzanian children. To determine whether a multifactorial falls prevention program reduces falls in people with stroke at risk of recurrent falls and whether this program leads to improvements in gait, balance, strength, and fall-related efficacy.
                A single blind, multicenter, randomized controlled trial with 12-month follow-up.
                Participants were recruited after discharge from rehabilitation and followed up in the community.
                Participants (N=156) were people with stroke at risk of recurrent falls being discharged home from rehabilitation.
                Tailored multifactorial falls prevention program and usual care (n=71) or control (usual care, n=85).
                Primary outcomes were rate of falls and proportion of fallers. Secondary outcomes included injurious falls, falls risk, participation, activity, leg strength, gait speed, balance, and falls efficacy.
                There was no significant difference in fall rate (intervention: 1.89 falls/person-year, control: 1.76 falls/person-year, incidence rate ratio=1.10, P=.74) or the proportion of fallers between the groups (risk ratio=.83, 95% confidence interval=.60-1.14). There was no significant difference in injurious fall rate (intervention: .74 injurious falls/person-year, control: .49 injurious falls/person-year, incidence rate ratio=1.57, P=.25), and there were no significant differences between groups on any other secondary outcome.
                This multifactorial falls prevention program was not effective in reducing falls in people with stroke who are at risk of falls nor was it more effective than usual care in improving gait, balance, and strength in people with stroke. Further research is required to identify effective interventions for this high-risk group.
                Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved. Fifty-one healthy prepubertal schoolchildren were followed for 13 months in a double blind study. Twenty-four of them were supplemented with 400 IU of vitamin D2 5-7 times weekly, while 27 received a placebo. The children were examined in winter both at the beginning and at the end of the study, and in the middle of the study in autumn. Mean 25-hydroxyvitamin D levels in the supplemented group were significantly higher than those in the placebo group both in autumn and in winter, when the study ended. The vitamin D supplementation did not, however, affect other vitamin D metabolites, serum calcium, albumin, inorganic phosphorus, parathyroid hormone concentrations or alkaline phosphatase activity. Moreover, the supplementation caused no alterations in the weight or height gain or bone mineral content of the distal radius of the children, and thus subclinical rickets could not be shown. To determine the effect of four monthly vitamin D supplementation on the rate of fractures in men and women aged 65 years and over living in the community.
                Randomised double blind controlled trial of 100 000 IU oral vitamin D3 (cholecalciferol) supplementation or matching placebo every four months over five years.
                2686 people (2037 men and 649 women) aged 65-85 years living in the general community, recruited from the British doctors register and a general practice register in Suffolk.
                Fracture incidence and total mortality by cause.
                After five years 268 men and women had incident fractures, of whom 147 had fractures in common osteoporotic sites (hip, wrist or forearm, or vertebrae). Relative risks in the vitamin D group compared with the placebo group were 0.78 (95% confidence interval 0.61 to 0.99, P=0.04) for any first fracture and 0.67 (0.48 to 0.93, P=0.02) for first hip, wrist or forearm, or vertebral fracture. 471 participants died. The relative risk for total mortality in the vitamin D group compared with the placebo group was 0.88 (0.74 to 1.06, P=0.18). Findings were consistent in men and women and in doctors and the general practice population.
                Four monthly supplementation with 100 000 IU oral vitamin D may prevent fractures without adverse effects in men and women living in the general community. Falls, loss of health-related quality of life and physical capacity, reduced participation in activities of daily living, and increased fear of falling are all potential outcomes for older adults discharged from hospital. A low-cost video based exercise programme may address this.
                This study was a randomized controlled trial with blinded outcomes assessment and a six-month follow-up.
                Participants were older adults (>65 years) using a mobility aid discharged from a tertiary hospital in Brisbane, Australia, without referral for community-based rehabilitation services.
                A digital video disk-based programme encompassing six exercise types each with six levels of difficulty. A home visit from a project physiotherapist was conducted to ensure patient safety. Control group patients received usual care.
                Falls, health-related quality of life, participation in activities of daily living, physical capacity and fear of falling.
                Study participants (n = 53, 19 intervention, 34 control) experienced decreasing health-related quality of life, several falls (72), and lower levels of participation in activities of daily living over the six-month follow-up. The intervention group did not differ significantly from the control group in terms of the outcomes examined, though a non-significant reduction in the rate of falls was observed. Intervention group participants complied with the exercise programme well during the first two weeks following discharge from hospital but then reduced their compliance levels thereafter.
                The intervention may be beneficial for reducing the rate of falls in this patient population though further research with a larger sample size is indicated. This study aimed to develop a multifaceted strategy using tailored interventions to implement a fall prevention programme, and to achieve a change in fall prevention practices and a reduction in fall incidence at an acute care hospital in Singapore.
                A comparative study was conducted at two acute care hospitals (intervention and control) in Singapore. Pre-intervention, post-intervention and six-month follow-up knowledge assessments of 641 nursing staff, and audits of fall rates and fall prevention practices were performed to determine the effectiveness of a multifaceted strategy with targeted interventions in supporting the implementation of a fall prevention programme.
                The mean post-knowledge test scores at six months were statistically significantly higher (t[516] is -3.3, p-value is less than 0.01) at the intervention hospital (10.3 +/- 2.3) compared to the scores at the control hospital (9.8 +/- 1.8). Increased compliance with the use of fall risk assessment tools was evident in 99.4 percent and 99.3 percent of all patient records at the control and intervention hospitals, respectively. Following the implementation strategy for a fall prevention programme, there was a non-significant reduction in fall rates from 1.44 to 1.09 per 1,000 patient days at the intervention hospital. No reduction in the fall rate was observed at the control hospital.
                A multifaceted strategy for the implementation of a fall prevention programme was effective in increasing nurses' knowledge and the use of the fall risk assessment, but did not have a statistically significant impact on a reduction in the fall rate. The increase in nurses' knowledge and change in nursing practice were important markers of success in terms of fall prevention at the acute hospitals. Vitamin D insufficiency is common in patients with osteoporosis. We conducted a randomized trial comparing alendronate 70 mg combined with vitamin D(3) 5,600 IU in a single tablet (ALN/D5600, n = 257) with standard care chosen by the patients' personal physicians (n = 258) in patients with postmenopausal osteoporosis (BMD T score ≤2.5 or ≤1.5 and a prior fragility fracture) who had vitamin D insufficiency (serum 25[OH]D values 8-20 ng/ml) and who were at risk of falls. Virtually all patients randomized to standard care received bisphosphonate therapy, and in approximately 70% of cases this was combined with vitamin D supplements. However, only 24% took ≥800 IU/day of supplemental vitamin D. At 6 months the proportion of patients with vitamin D insufficiency was 8.6% in the ALN/D5600 group compared with 31.0% in the standard care group (P < 0.001). Those in the ALN/D5600 group also had a greater reduction in urinary NTX/creatinine ratio (-57% vs. -46%, P < 0.001) and bone-specific alkaline phosphatase (-47% vs. -40%, P < 0.001). In the ALN/5600 group, by 12 months the increase in BMD was greater at the lumbar spine (4.9% vs. 3.9%, P = 0.047) and the total hip (2.2% vs. 1.4%, P = 0.035), significantly fewer patients were vitamin D-insufficient (11.3% vs. 36.9%, P < 0.001), and bone turnover marker (BTM) results were similar to those at 6 months. There was no difference between groups in those who experienced falls or fractures, and adverse events were similar. Based on the finding that ALN/D5600 was more effective than standard care at correcting vitamin D insufficiency, increasing BMD, and reducing BTMs in this patient group, greater attention needs to be directed toward optimizing the treatment of osteoporosis and correcting vitamin D deficiency in postmenopausal women. To determine the effectiveness of multifactorial intervention to prevent falls in cognitively intact older persons with recurrent falls.
                Randomised controlled trial of multifactorial (medical, physiotherapy and occupational therapy) post-fall assessment and intervention compared with conventional care.
                Accident & Emergency departments in a university teaching hospital and associated district general hospital.
                313 cognitively intact men and women aged over 65 years presenting to Accident & Emergency with a fall or fall-related injury and at least one additional fall in the preceding year; 159 randomised to assessment and intervention and 154 to conventional care. Outcome measures: primary outcome was the number of falls and fallers in 1 year after recruitment. Secondary outcomes included injury rates, fall-related hospital admissions, mortality and fear of falling.
                There were 36% fewer falls in the intervention group (relative risk 0.64, 95% confidence interval 0.46-0.90). The proportion of subjects continuing to fall (65% (94/144) compared with 68% (102/149) relative risk 0.95, 95% confidence interval 0.81-1.12), and the number of fall-related attendances and hospital admissions was not different between groups. Duration of hospital admission was reduced (mean difference admission duration 3.6 days, 95% confidence interval 0.1-7.6) and falls efficacy was better in the intervention group (mean difference in Activities Specific Balance Confidence Score of 7.5, 95% confidence interval 0.72-14.2).
                Multifactorial intervention is effective at reducing the fall burden in cognitively intact older persons with recurrent falls attending Accident & Emergency, but does not reduce the proportion of subjects still falling. To evaluate the effect of multifactorial fall prevention in community-dwelling people aged 65 and older in Denmark.
                Randomized, controlled clinical trial.
                Geriatric outpatient clinic at Glostrup University Hospital.
                Three hundred ninety-two elderly people, mean age 74, 73.7%women, who had visited the emergency department or had been hospitalized due to a fall.
                Identification of general medical, cardiovascular, and physical risk factors for falls and individual intervention in the intervention group. Participants in the control group received usual care.
                Falls were registered prospectively in falls diaries, with monthly telephone calls for collection of data. Outcomes were fall rates and proportion of participants with falls, frequent falls, and injurious falls in 12 months.
                Groups were comparable at baseline. Followup exceeded 90.0%. A total of 422 falls were registered in the intervention group, 398 in the control group. Intention-to-treat analysis revealed no effect of the intervention on fall rates (relative risk=1.06, 95%confidence interval (CI)=0.75 -1.51), proportion with falls (odds ratio (OR)=1.20, 95% CI 0.81-1.79), frequent falls (OR=0.97, 95% CI=0.60-1.56), or injurious falls (OR=0.97, 95% CI=0.57-1.62).
                A program of multifactorial fall prevention aimed at elderly Danish people experiencing at least one injurious fall was not effective in preventing further falls. Long-term vitamin D and calcium supplementation is effective in reducing nonvertebral fractures in elderly people. Increased bone fragility caused by secondary hyperparathyroidism (sHPT) and impaired balance are known risk factors for hip fractures. The hypothesis is that short-term therapy with calcium and vitamin D may improve body sway as well as sHPT more effectively than calcium monotherapy. The effects of 8 weeks of supplementation with vitamin D (cholecalciferol) and calcium on body sway and biochemical measures of bone metabolism were measured. The sample consisted of 148 women (mean [+/-SD] age, 74 +/- 1 years) with a 25-hydroxycholecalciferol level below 50 nmol/liter. They received either 1200 mg of calcium plus 800 IU of vitamin D or 1200 mg of calcium per day. We measured intact parathyroid hormone (PTH), markers of bone turnover, and body sway before and after treatment. Falls and fractures among the participants were followed over a 1-year period. Compared with calcium mono, supplementation with vitamin D and calcium resulted in an increase in serum 25-hydroxyvitamin D of 72% (p < 0.0001), a decrease in the serum PTH of 18% ( p = 0.0432), and a decrease in body sway of 9% (p = 0.0435). The mean number of falls per subject during a 1-year follow-up period was 0.45 for the calcium mono group and 0.24 for the calcium and vitamin D group (p = 0.0346). Short-term supplementation with vitamin D and calcium improves sHPT and body sway and therefore may prevent falls and subsequent nonvertebral fractures in elderly women. To evaluate the effect of vitamin and mineral supplementation on infections in an elderly institutionalized population.
                Eighteen-month, randomized, placebo-controlled trial.
                Twenty-one long-term care facilities.
                Seven hundred sixty-three subjects from 21 long-term care facilities.
                Participants were randomized to receive one multivitamin and mineral supplementation daily or placebo.
                The primary outcome was number of infections per subject. Secondary outcomes were antibiotic use and hospitalization rates. Infection control surveillance was conducted over 18 months using standardized criteria.
                Outcome data from 748 subjects, mean age 85, were included in the intention-to-treat analysis. Using univariate analyses, there was no difference in infectious episodes between the supplemented and placebo groups (3.5 infections per 1,000 resident-days vs 3.8 infections per 1,000 resident-days, odds ratio (OR)=0.92, 95% confidence interval (CI)=0.82-1.03, P=.12). There was a reduction in antibiotic usage in the supplementation group, but this was not significant in the multivariate model. There was no difference in the number of hospital visits. In the multivariate analysis, the effect of multivitamin use on total number of infections was not significant (OR=0.77, 95% CI=0.54-1.1). Subjects without dementia had a greater rate of infections than those with dementia (OR=1.44, 95% CI=1.19-1.76). In post hoc subgroup analysis, subjects without dementia who received supplementation had a significantly lower rate of infections than those who received placebo (relative risk=0.81, 95% CI=0.66-0.99).
                Overall, multivitamin and mineral supplementation does not have a significant effect on the incidence of infections in institutionalized seniors, although the subgroup of residents in long-term care without dementia may benefit from supplementation. Further research is needed to determine its effect in high-risk subgroups within the nursing home population. Hypovitaminosis D and a low calcium intake contribute to increased parathyroid function in elderly persons. Calcium and vitamin D supplements reduce this secondary hyperparathyroidism, but whether such supplements reduce the risk of hip fractures among elderly people is not known.
                We studied the effects of supplementation with vitamin D3 (cholecalciferol) and calcium on the frequency of hip fractures and other nonvertebral fractures, identified radiologically, in 3270 healthy ambulatory women (mean [+/- SD] age, 84 +/- 6 years). Each day for 18 months, 1634 women received tricalcium phosphate (containing 1.2 g of elemental calcium) and 20 micrograms (800 IU) of vitamin D3, and 1636 women received a double placebo. We measured serial serum parathyroid hormone and 25-hydroxyvitamin D (25(OH)D) concentrations in 142 women and determined the femoral bone mineral density at base line and after 18 months in 56 women.
                Among the women who completed the 18-month study, the number of hip fractures was 43 percent lower (P = 0.043) and the total number of nonvertebral fractures was 32 percent lower (P = 0.015) among the women treated with vitamin D3 and calcium than among those who received placebo. The results of analyses according to active treatment and according to intention to treat were similar. In the vitamin D3-calcium group, the mean serum parathyroid hormone concentration had decreased by 44 percent from the base-line value at 18 months (P < 0.001) and the serum 25(OH)D concentration had increased by 162 percent over the base-line value (P < 0.001). The bone density of the proximal femur increased 2.7 percent in the vitamin D3-calcium group and decreased 4.6 percent in the placebo group (P < 0.001).
                Supplementation with vitamin D3 and calcium reduces the risk of hip fractures and other nonvertebral fractures among elderly women. To assess whether a multifactorial fall prevention program was more effective than usual geriatric care in preventing falls and reducing fear of falling in frail community-dwelling older fallers, with and without cognitive impairment, and in alleviating subjective caregiver burden in caregivers.
                A randomized, 2 parallel-group, single-blind, multicenter trial conducted in 36 pairs of frail fallers, who were referred to a geriatric outpatient clinic after at least 1 fall in the past 6 months, and their informal caregivers.
                Groups of 5 pairs of patients and caregivers received 10 twice-weekly, 2-hour sessions with physical and psychological components and a booster session.
                The primary outcome was the fall rate during a 6-month follow-up. Additionally, we measured fear of falling and subjective caregiver burden. Data on the secondary outcome measures were collected at baseline, directly after, and at 3 and 6 months after the last session of the intervention.
                Directly after the intervention and at the long-term evaluation, the rate of falls in the intervention group was higher than in the control group, although these differences were not statistically significant (RR = 7.97, P = .07 and RR = 2.12, P = .25, respectively). Fear of falling was higher in the intervention group, and subjective caregiver burden did not differ between groups.
                Although we meticulously developed this pairwise multifactorial fall prevention program, it was not effective in reducing the fall rate or fear of falling and was not feasible for caregivers, as compared with regular geriatric care. Future research initiatives should be aimed at how to implement the evidence-based principles of geriatric fall prevention for all frail fallers rather than developing more complex interventions for the frailest.
                Copyright © 2011 American Medical Directors Association. Published by Elsevier Inc. All rights reserved. We conducted a randomized, double-blind, controlled trial to determine whether vitamin A supplementation from early postnatal life could reduce the morbidity associated with bronchopulmonary dysplasia in very low birth weight (VLBW) neonates. Forty VLBW neonates (700 to 1300 g birth weight, 26 to 30 weeks gestational age), who were oxygen dependent and required mechanical ventilation for at least 72 hours after birth, were given by the intramuscular route either supplemental vitamin A (retinyl palmitate 2000 IU) or 0.9% saline solution on postnatal day 4 and every other day thereafter for a total of 14 injections over 28 days. The study groups were comparable in gestational maturity, clinical characteristics, initial lung disease, and vitamin A status at entry into the trial. Vitamin A administration resulted in significantly higher mean plasma concentrations of vitamin A and retinol-binding protein in treated infants compared with controls. Bronchopulmonary dysplasia was diagnosed in nine of 20 infants given vitamin A supplement and in 17 of 20 control infants (P less than 0.008). Four of 19 infants in the vitamin A group and 11 of 20 in the control group required mechanical ventilation on study day 28 (P less than 0.029). The need for supplemental oxygen, mechanical ventilation, and intensive care was reduced in infants given vitamin A supplement compared with controls. Airway infection and retinopathy of prematurity were less frequent in the vitamin A group. We conclude that vitamin A supplementation at the dosage used in this trial in VLBW neonates not only improves their vitamin A status but also appears to promote regenerative healing from lung injury, as evidenced by a decrease in the morbidity associated with bronchopulmonary dysplasia. Despite the high prevalence of hypovitaminosis D in children and adolescents worldwide, the impact of vitamin D deficiency on skeletal health is unclear.
                One hundred seventy-nine girls, ages 10-17 yr, were randomly assigned to receive weekly oral vitamin D doses of 1,400 IU (equivalent to 200 IU/d) or 14,000 IU (equivalent to 2,000 IU/d) in a double-blind, placebo-controlled, 1-yr protocol. Areal bone mineral density (BMD) and bone mineral content (BMC) at the lumbar spine, hip, forearm, total body, and body composition were measured at baseline and 1 yr. Serum calcium, phosphorus, alkaline phosphatase, and vitamin D metabolites were measured during the study.
                In the overall group of girls, lean mass increased significantly in both treatment groups (P < or = 0.05); bone area and total hip BMC increased in the high-dose group (P < 0.02). In premenarcheal girls, lean mass increased significantly in both treatment groups, and there were consistent trends for increments in BMD and/or BMC at several skeletal sites, reaching significance at lumbar spine BMD in the low-dose group and at the trochanter BMC in both treatment groups. There was no significant change in lean mass, BMD, or BMC in postmenarcheal girls.
                Vitamin D replacement had a positive impact on musculoskeletal parameters in girls, especially during the premenarcheal period. to assess whether specialist osteoporosis nurses delivering training to care home staff can reduce fractures and improve the prescription of treatments to reduce fractures versus usual care.
                pragmatic cluster randomised controlled trial (RCT) with randomisation at the Primary Care Organisation (PCO) level.
                care homes (residential, nursing and EMI) across England and Wales within PCOs.
                all 300 PCOs in England and Wales were invited to take part. Of these, 58 agreed to participate and gained ethical approval in time to start the study: 29 clusters were randomised to the intervention group and 29 to the control.
                specialist osteoporosis nurses undertaking short training sessions with care home staff emphase the importance of fracture and fall prevention and train staff on how to identify those residents at high risk of fracture. Residents' risk of fracture and falls was reported to general practitioners (GPs) of patients along with treatment recommendations.
                primary outcome measures were total fractures over the past 12 months and total hip fractures over past the 12 months. Secondary outcome measures were total home falls, number of residents sustaining a fall, number of residents prescribed bisphosphonates, number of residents prescribed calcium and vitamin D and number of residents wearing hip protectors. All outcomes were measured at the care home level.
                of the 230 care homes randomised data were collected from 209 of these containing 5,637 residents. There were no differences between the groups in the incidence rate ratios (IRRs) for total fractures (IRR = 0.94 [0.71, 1.26] P = 0.70) or total hip fractures (IRR = 0.86 [0.63, 1.18] P = 0.36). No differences were found between groups for home falls or hip protector use. A significant increase in bisphosphonate prescription was seen in the intervention group over the control group (IRR = 1.50 [1.00, 2.24] P = 0.05). Calcium and vitamin D prescription was significantly increased in the intervention group over the control group (IRR = 1.64 [1.23, 2.18] P<0.01).
                the intervention significantly increased the prescription of bisphosphonates and calcium/vitamin D, but was not associated with a significant effect on the rate of falls or fractures. Although vitamin D supplementation has been suggested to reduce the risk of falling in ambulatory or institutionalized elderly persons, no study has examined whether it reduces the frequency of falling in immobilized stroke patients who have immobilization-induced hypercalcemia reflecting increased bone resorption leading to inhibited renal synthesis of 1, 25-dihydroxyvitamin D (1, 25-[OH]2D). Bisphosphonate is known to reduce immobilization-induced hypercalcemia by inhibiting bone resorption of calcium. This study compared the efficacy of 2 drugs in reducing the risk of falling in patients with long-standing stroke. Eighty-two elderly patients with poststroke hemiparesis were followed for 1 year. The patients were randomly assigned to one of 2 groups; 41 patients received alendronate 35 mg once weekly, and 41 patients received alphacalcidiol 1 μg daily. The number of falls per person and incidence of hip fracture in the 2 groups were compared. At baseline, all patients had a low serum 1, 25-[OH]2D level. Alphacalcidol therapy enhanced immobilization-induced hypercalcemia by increasing intestinal calcium absorption, leading to a reduction of serum 1, 25-[OH]2D level, while alendronate therapy enhanced 1, 25-[OH]2D production by decreasing hypercalcemia. Alendronate treatment accounted for a 55% reduction in falls (95% confidence interval [CI]=25-72%; P=.0021). During the 1-year study period, hip fracture occurred in 1 of 41 subjects in the alphacalcidol group and in no subjects in the alendronate group. Bone mineral density was increased by 3.2% in the alendronate group and decreased by 0.1% in the alphacalcidol group (P<.0001). Alendronate therapy increased serum 1, 25-[OH]2D levels by improving immobilization-induced hypercalcemia, which may lead to decreased falling and subsequent hip fractures.
                Copyright Â© 2011 National Stroke Association. Published by Elsevier Inc. All rights reserved.
In care facilities, vitamin D supplementation is effective in reducing the rate of falls. Exercise in subacute hospital settings appears effective but its effectiveness in care facilities remains uncertain due to conflicting results, possibly associated with differences in interventions and levels of dependency. There is evidence that multifactorial interventions reduce falls in hospitals but the evidence for risk of falling was inconclusive. Evidence for multifactorial interventions in care facilities suggests possible benefits, but this was inconclusive.