Randomized controlled trial of nutritional supplementation in patients with newly diagnosed tuberculosis and wasting. Randomised controlled trial of food supplements in patients with newly diagnosed tuberculosis and wasting. Pilot randomized trial of nutritional supplementation in patients with tuberculosis and HIV-tuberculosis coinfection receiving directly observed short-course chemotherapy for tuberculosis. Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste. The effect of energy-protein supplementation on weight, body composition and handgrip strength among pulmonary tuberculosis HIV-co-infected patients: randomised controlled trial in Mwanza, Tanzania. A trial of the effect of micronutrient supplementation on treatment outcome, T cell counts, morbidity, and mortality in adults with pulmonary tuberculosis. Benefits of nutritional supplementation in free-living, frail, undernourished elderly people: a prospective randomized community trial. The effect of vitamin A and zinc supplementation on treatment outcomes in pulmonary tuberculosis: a randomized controlled trial. Adjunctive micronutrient supplementation for pulmonary tuberculosis. Daily multi-micronutrient supplementation during tuberculosis treatment increases weight and grip strength among HIV-uninfected but not HIV-infected patients in Mwanza, Tanzania. Zinc and vitamin A supplementation fails to reduce sputum conversion time in severely malnourished pulmonary tuberculosis patients in Indonesia. Vitamin D as supplementary treatment for tuberculosis: a double-blind, randomized, placebo-controlled trial. The effect of vitamin D as supplementary treatment in patients with moderately advanced pulmonary tuberculous lesion. Subjectively healthy elderly consuming a liquid nutrition supplement maintained body mass index and improved some nutritional parameters and perceived well-being. The effect of micronutrient supplementation on treatment outcome in patients with pulmonary tuberculosis: a randomized controlled trial in Mwanza, Tanzania. The effect of multi-vitamin/mineral supplementation on mortality during treatment of pulmonary tuberculosis: a randomised two-by-two factorial trial in Mwanza, Tanzania. Oral supplements as adjunctive treatment to nutritional counseling in malnourished HIV-infected patients: randomized controlled trial. A randomized controlled trial evaluating nutrition counseling with or without oral supplementation in malnourished HIV-infected patients. Should oral nutritional supplementation be given to undernourished older people upon hospital discharge? A controlled trial. Dietary counseling improves patient outcomes: a prospective, randomized, controlled trial in colorectal cancer patients undergoing radiotherapy. Providing nutrition supplements to institutionalized seniors with probable Alzheimer's disease is least beneficial to those with low body weight status.
Nutritional support is often recommended as part of the treatment of tuberculosis, but it has never been properly tested.
                We assessed the effects of early nutritional intervention on lean mass and physical function in patients with tuberculosis and wasting.
                Patients who started antituberculous therapy within the previous 2 wk were randomly assigned to receive standard nutritional counseling (control group) or nutritional counseling to increase their intake through diet and high-energy supplements (nutritional supplement group) for 6 wk. Body composition was measured by dual-energy X-ray absorptiometry, and physical function was assessed by maximum grip strength.
                Patients in the nutritional supplement group (n = 19) had a significantly greater increase in body weight (2.57 +/- 1.78 compared with 0.84 +/- 0.89 kg, P = 0.001), total lean mass (1.17 +/- 0.93 compared with 0.04 +/- 1.26 kg, P = 0.006), and grip strength (2.79 +/- 3.11 compared with -0.65 +/- 4.48 kg, P = 0.016) than did the control subjects (n = 17) at week 6. During subsequent follow-up, the increase in body weight remained greater in the nutritional supplement group, but this increase was due mainly to a greater gain in fat mass in the nutritional supplement group than in the control group.
                Early intervention to increase nutritional intake increases lean mass and physical function. This adjunct to tuberculosis therapy could confer socioeconomic and survival benefits that deserve investigation in large-scale trials. Nutritional intervention after the initial phase of treatment could be less beneficial because it mainly increases fat. Wasting is the cardinal feature of tuberculosis, but not much documentary evidence supporting food supplements exists. This study was done to assess the effects of food supplements on body weight, physical function, quality of life and treatment outcomes in patients with tuberculosis and wasting.
                The study was conducted in 30 Anganwadi centres of 16 villages in the catchment area of Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation and the Gannavaram Directly Observed Treatment Short Course chemotherapy centre from August 2005 to December 2005. A total of 100 patients participated in the study. Patients who were started on anti-tubercular therapy within the previous two weeks were randomly assigned to either the control or the food supplement group. At the end of three months, their body weight was measured and physical function and quality of life were assessed. Treatment outcomes were assessed at the one-year follow-up for both groups.
                Patients who received supplements had a significant increase in body weight (8.6 percent versus 2.6 percent, p-value less than 0.001) and maximum grip strength (p-value less than 0.001), a higher sputum conversion rate (p-value is 0.039), a higher treatment completion rate (p-value is 0.031) and improvements in the quality of life scores.
                Intake of food supplements resulted in a definitive increase in body weight and physical function in our study sample. Improvements can be observed in all areas, including psychologically, physiologically, socially and in the treatment outcomes. To investigate the effects of nutritional supplementation on the outcome and nutritional status of south Indian patients with tuberculosis (TB) with and without human immunodeficiency virus (HIV) coinfection on anti-tuberculous therapy.
                Randomized controlled trial on the effect of a locally prepared cereal-lentil mixture providing 930 kcal and a multivitamin micronutrient supplement during anti-tuberculous therapy in 81 newly diagnosed TB alone and 22 TB-HIV-coinfected patients, among whom 51 received and 52 did not receive the supplement. The primary outcome evaluated at completion of TB therapy was outcome of TB treatment, as classified by the national programme. Secondary outcomes were body composition, compliance and condition on follow-up 1 year after cessation of TB therapy and supplementation.
                There was no significant difference in TB outcomes at the end of treatment, but HIV-TB coinfected individuals had four times greater odds of poor outcome than those with TB alone. Among patients with TB, 1/35 (2.9%) supplemented and 5/42(12%) of those not supplemented had poor outcomes, while among TB-HIV-coinfected individuals, 4/13 (31%) supplemented and 3/7 (42.8%) non-supplemented patients had poor outcomes at the end of treatment, and the differences were more marked after 1 year of follow-up. Although there was some trend of benefit for both TB alone and TB-HIV coinfection, the results were not statistically significant at the end of TB treatment, possibly because of limited sample size.
                Nutritional supplements in patients are a potentially feasible, low-cost intervention, which could impact patients with TB and TB-HIV. The public health importance of these diseases in resource-limited settings suggests the need for large, multi-centre randomized control trials on nutritional supplementation.
                © 2011 Blackwell Publishing Ltd. To determine the effectiveness of the provision of whole food to enhance completion of treatment for tuberculosis.
                Parallel group randomised controlled trial.
                Three primary care clinics in Dili, Timor-Leste.
                270 adults aged >or=18 with previously untreated newly diagnosed pulmonary tuberculosis.
                Completion of treatment (including cure). Secondary outcomes included adherence to treatment, weight gain, and clearance of sputum smears. Outcomes were assessed remotely, blinded to allocation status. Interventions Participants started standard tuberculosis treatment and were randomly assigned to intervention (nutritious, culturally appropriate daily meal (weeks 1-8) and food package (weeks 9-32) (n=137) or control (nutritional advice, n=133) groups. Randomisation sequence was computer generated with allocation concealment by sequentially numbered, opaque, sealed envelopes.
                Most patients with tuberculosis were poor, malnourished men living close to the clinics; 265/270 (98%) contributed to the analysis. The intervention had no significant beneficial or harmful impact on the outcome of treatment (76% v 78% completion, P=0.7) or adherence (93% for both groups, P=0.7) but did lead to improved weight gain at the end of treatment (10.1% v 7.5% improvement, P=0.04). Itch was more common in the intervention group (21% v 9%, P<0.01). In a subgroup analysis of patients with positive results on sputum smears, there were clinically important improvements in one month sputum clearance (85% v 67%, P=0.13) and completion of treatment (78% v 68%, P=0.3).
                Provision of food did not improve outcomes with tuberculosis treatment in these patients in Timor-Leste. Further studies in different settings and measuring different outcomes are required.
                Clinical Trials NCT0019256. Undernutrition is common among smear-positive pulmonary tuberculosis (PTB+) patients. Micronutrient supplementation may improve treatment outcomes, but it is unclear whether additional energy-protein would be beneficial. The present study aimed to assess the effect of energy-protein supplementation on weight, body composition and handgrip strength against a background of high micronutrient intake during tuberculosis (TB) treatment. A total of 377 PTB+ patients co-infected with HIV were randomly allocated one or six biscuits daily for 60 d during TB treatment. Weight, arm fat area, arm muscle area and handgrip strength were assessed at baseline and 2 and 5 months. There were no effects on any outcome at 2 months, but energy-protein supplementation was associated with a 1·3 (95 % CI - 0·1, 2·8) kg marginally significant gain in handgrip strength at 5 months. However, after 2 months, energy-protein supplementation led to a weight gain of 1·9 (95 % CI 0·1, 3·7) kg among patients with cluster of differentiation 4 (CD4) counts ≥ 350 cells/μl, but not among patients with low CD4 counts ( - 0·2 kg; 95 % CI - 1·3, 0·8, Pinteraction = 0·03). Similarly, at 5 months, energy-protein supplementation led to a 2·3 (95 % CI 0·6, 4·1) kg higher handgrip strength gain among patients with CD4 counts < 350 cells/μl, but not in those with high CD4 counts (Pinteraction = 0·04). In conclusion, energy-protein supplementation to PTB+ HIV-co-infected patients had no overall effects on weight and body composition, but was associated with marginally significant gain in handgrip strength. More research is needed to develop an effective supplement, before it is recommended to TB programmes. Tuberculosis (TB) often coincides with nutritional deficiencies. The effects of micronutrient supplementation on TB treatment outcomes, clinical complications, and mortality are uncertain.
                We conducted a randomized, double-blind, placebo-controlled trial of micronutrients (vitamins A, B complex, C, and E, as well as selenium) in Dar es Salaam, Tanzania. We enrolled 471 human immunodeficiency virus (HIV)-infected and 416 HIV-negative adults with pulmonary TB at the time of initiating chemotherapy and monitored them for a median of 43 months.
                Micronutrients decreased the risk ofTB recurrence by 45% overall (95% confidence interval [CI], 7% to 67%; P = .02) and by 63% in HIV-infected patients (95% CI, 8% to 85%; P = .02). There were no significant effects on mortality overall; however, we noted a marginally significant 64% reduction of deaths in HIV-negative subjects (95% CI, -14% to 88%; P = .08). Supplementation increased CD3+ and CD4+ cell counts and decreased the incidence of extrapulmonary TB and genital ulcers in HIV-negative patients. Micronutrients reduced the incidence of peripheral neuropathy by 57% (95% CI, 41% to 69%; P < .001), irrespective of HIV status. There were no significant effects on weight gain, body composition, anemia, or HIV load.
                Micronutrient supplementation could improve the outcome in patients undergoing TB chemotherapy in Tanzania. To evaluate the impact of nutritional supplementation on nutritional status, muscle strength, perceived health, and functional status in a population of community-living, frail, undernourished elderly people.
                A 16-week intervention study in which subjects were randomized to an experimental or a control group and visited in their home on a monthly basis. Outcome variables were measured at the start and end of the study at subjects' homes by a dietitian blinded to treatment assignment.
                83 elderly people (experimental group: n=42; control group: n=41; mean age=80+/-7 years) receiving community home-care services and at high risk for undernutrition.
                Provision of a nutrient-dense protein-energy liquid supplement and encouragement to improve intake from other foods.
                Anthropometric indexes, handgrip strength, isometric elbow flexion and leg extension strength, lower extremity function, perceived health, and functional status.
                Study groups were compared on an "intention to treat" basis using analysis of variance for repeated measures and unpaired and paired t tests and their nonparametric equivalents where appropriate.
                Total energy intake (1,772 vs 1,440 kcal; P<.001) and weight gain (1.62 vs 0.04 kg; P<.001) were higher in the supplemented group. No significant changes were observed with respect to other anthropometric indexes, muscle strength, or functional variables; however, beneficial effects were observed in emotional role functioning (P<0.01) and number of days spent in bed (P=.04).
                Nutrition intervention is feasible in free-living, frail, undernourished elderly people and results in significant improvement of nutritional status with respect to energy and nutrient intake and weight gain. Weight loss can be stopped and in some cases reversed; however, increased physical activity may also be required to improve health and functional status. Low serum concentrations of vitamin A and zinc are common in tuberculosis and may have an adverse effect on host cell-mediated responses. The role of adjunctive micronutrient supplementation on treatment outcomes is uncertain.
                The objective was to assess the efficacy of vitamin A and zinc supplementation on sputum smear and culture conversion and time to culture detection in adults with sputum smear-positive pulmonary tuberculosis.
                Participants attending a primary care tuberculosis clinic in Cape Town, South Africa, were randomly assigned to receive micronutrients (single dose of 200,000 IU retinyl palmitate plus 15 mg Zn/d for 8 wk) or matching placebo. Sputum was collected weekly for 8 wk for auramine staining and culture on liquid media (BACTEC MGIT 960; Becton Dickinson, Sparks, MD). Performance status, chest radiographs, and anthropometric measures were assessed at baseline and again at 8 wk.
                The participants (n = 154) were randomly assigned to the micronutrient (n = 77) or placebo (n = 77) group. Twenty participants were HIV infected (13%), and 12 participants had an unknown HIV status (8%). No differences in time to smear or culture conversion were observed between the treatment groups by Kaplan-Meier analysis (P = 0.15 and P = 0.38, respectively; log-rank test). Log-logistic regression analysis found no significant group interaction effect in time to culture detection over the 8-wk period (P = 0.32). No significant differences in weight gain (2.3 ± 3.5 compared with 2.2 ± 2.4 kg, P = 0.68) or radiologic resolution were observed between the treatment groups.
                Supplementation with vitamin A and zinc did not affect treatment outcomes in participants with pulmonary tuberculosis at 8 wk. This trial was registered at controlled-trials.com as ISRCTN80852505. To assess the effect of micronutrient supplementation on tuberculosis (TB) patient outcomes.
                The randomized, double-blinded, placebo-controlled study was conducted in pulmonary TB patients undergoing directly observed treatment short course/ tratamiento acortado estrictamente supervisado (TAES/ DOTS) at IMSS in Ciudad Juarez, Chihuahua, Mexico, who were recruited during August 2005-July 2006. Consecutive patients received zinc and vitamin A supplements or matched placebo for four months. Dietary intake, blood zinc and vitamin A, immune response (IFN-gamma,TNF-alpha, and IL-10 mRNA), and sputum smear conversion were measured.
                The proportion of micronutrient compared to placebo group subjects with a negative sputum smear by month 3 was significantly increased (p= 0.03). This occurred subsequent to increased TNF-alpha and IFN-gamma and decreased IL-10 observed at month 2. Micronutrient supplementation appeared to accelerate the beneficial therapeutic effect of chemotherapy.
                The earlier elimination of bacilli from sputum was associated with improved zinc status and Th1 immune response. The therapeutic effect of vitamin A was less evident. Undernutrition is common among tuberculosis (TB) patients. The objective of this study was to assess the effect of multi-micronutrient supplementation during TB treatment on weight, body composition, and handgrip strength. A total of 865 patients with smear-positive (PTB+) or -negative (PTB-) pulmonary TB were randomly allocated to receive a daily biscuit with or without multi-micronutrients for 60 d during the intensive phase of TB treatment. Weight, arm fat area, arm muscle area, and handgrip strength were assessed at baseline and after 2 and 5 mo. At 2 mo, the multi-micronutrient supplementation led to a higher handgrip gain (1.22 kg; 95% CI = 0.50, 1.94; P = 0.001) but had no effects on other outcomes. The effects of multi-micronutrient supplementation were modified by HIV infection (P-interaction = 0.002). Among HIV- patients, multi-micronutrient supplementation increased weight gain by 590 g (95% CI = -40, 1210; P = 0.07) and handgrip strength by 1.6 kg (95% CI = 0.78, 2.47; P < 0.001), whereas among HIV+ patients, it reduced weight gain by 1440 g (95% CI = 290, 2590; P = 0.002) and had no effect on handgrip strength (0.07 kg; 95% CI = -1.30, 1.46; P = 0.91). The reduced weight gain among HIV+ patients receiving multi-micronutrient supplementation seemed to be explained by a higher proportion of patients reporting fever. At 5 mo, the effects on weight were sustained, whereas there was no effect on handgrip strength. In conclusion, multi-micronutrient supplementation given as a biscuit is beneficial among HIV- PTB patients and may be recommended to TB programs. More research is needed to develop an effective supplement for HIV+ PTB patients. A previous study showed that combination of zinc and vitamin A reduced sputum conversion time in pulmonary tuberculosis (TB) patients.
                We studied the efficacy of which single micronutrient contributed more to the sputum conversion time.
                In a double-blind randomized community trial, newly sputum smear positive pulmonary TB patients were assigned randomly to receive zinc, vitamin A, zinc + vitamin A or placebo on top of TB treatment. Patients were asked to deliver their sputum on weekly basis to measure positivity of the bacteria. Nutritional status, chest x-ray, hemoglobin, C-reactive protein (CRP), retinol and zinc level were examined prior to, after 2 and 6 months of treatment.
                Initially, 300 patients were enrolled, and 255 finished the treatment. Most patients were severely malnourished (mean BMI 16.5 ± 2.2 Kg/m2). Patients in the zinc + vitamin A group showed earlier sputum conversion time (mean 1.9 weeks) compared with that in the other groups; however the difference was not significant. Also, no benefit could be demonstrated of any of the used supplementations on clinical, nutritional, chest x-ray, or laboratory findings.
                This study among severely malnourished TB patients, did not confirm that single or combined supplementation of zinc and vitamin A significantly reduced sputum conversion time or had other significant benefit. Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis.
                To test whether vitamin D supplementation of patients with tuberculosis (TB) improved clinical outcome and reduced mortality.
                We conducted a randomized, double-blind, placebo-controlled trial in TB clinics at a demographic surveillance site in Guinea-Bissau. We included 365 adult patients with TB starting antituberculosis treatment; 281 completed the 12-month follow-up. The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months after the start of treatment.
                The primary outcome was reduction in a clinical severity score (TBscore) for all patients with pulmonary TB. The secondary outcome was 12-month mortality. No serious adverse effects were reported; mild hypercalcemia was rare and present in both arms. Reduction in TBscore and sputum smear conversion rates did not differ among patients treated with vitamin D or placebo. Overall mortality was 15% (54 of 365) at 1 year of follow-up and similar in both arms (30 of 187 for vitamin D treated and 24 of 178 for placebo; relative risk, 1.19 [0.58-1.95]). HIV infection was seen in 36% (131 of 359): 21% (76 of 359) HIV-1, 10% (36 of 359) HIV-2, and 5% (19 of 357) HIV-1+2.
                Vitamin D does not improve clinical outcome among patients with TB and the trial showed no overall effect on mortality in patients with TB; it is possible that the dose used was insufficient. Clinical trial registered with www.controlled-trials.com/isrctn (ISRCTN35212132). to compare the vitamin D group of pulmonary tuberculosis patients with a placebo group in terms of clinical improvement, nutritional status, sputum conversion, and radiological improvement.
                sixty seven tuberculosis patient visiting the Pulmonary Clinic, of Cipto Mangunkusumo Hospital, Jakarta, from January 1st to August 31st, 2001 were included in this study. The subjects were randomised to receive vitamin D (0.25 mg/day) or placebo in a double blind method, during the 6th initial week of Tb treatment. The rate of sputum conversion, complete blood counts, blood chemistry as well as radiologic examination were evaluated.
                there were more male patients than females (39:28), 78.7% were in the productive age group, 71.6% had low nutritional status, 62.4% with low education level, and 67.2% with low income. One hundred percent of the vitamin D group and only 76.7% of the placebo group had sputum conversion. This difference is statistically significant (p=0.002).
                the sputum conversion had no correlation with the hemoglobin level, blood clotting time, calcium level, lymphocyte count, age, sex, and nutritional status. There were more subjects with radiological improvement in the vitamin D group. To evaluate regular use of a liquid nutrition supplement by subjectively healthy elderly persons in terms of body mass index, nutrient intake, selected biochemical parameters, and perceived quality-of-life changes, and to identify advantages and limitations of use.
                A 16-week intervention study in which subjects were assigned randomly to either a supplemented group or a control group and compared in terms of intergroup and intragroup differences in weight, food intake, blood values, and quality-of-life indexes. Adherence to protocol was monitored by monthly visits with an interviewer and food intake records.
                Seventy-one independent living, older Canadian adults (mean age = 70 +/- 7 years) consuming on average less than 4 servings of fruit and vegetables daily and a supplement-free diet before the study. Subjects were without functional limitations and did not require therapeutic diets or medical treatments that affect nutritional status. Data were collected in home interviews. Blood for analysis was obtained from a subsample of 36 subjects.
                Inclusion of six 235-mL cans of liquid nutrition supplement weekly into the self-selected dietary patterns of the supplemented group.
                Results were analyzed by Student t tests or Wilcoxon rank sum test, analysis of variance, and multiple stepwise regression.
                Body mass index, energy intake, and consumption of fruit and vegetables did not change throughout the study. In the supplemented group, statistically significant increases occurred from baseline to termination of the study in these nutrients: protein, calcium, iron, magnesium, and folate. Serum albumin, folate, ferritin, hemoglobin, and zinc values were within the normal range for the supplemented and control groups. Scores for the Medical Outcomes Study 36-Item Short-Form Health Status scales increased for the supplemented group from baseline to termination for vitality and general health perception. Values for the General Well-Being Questionnaire improved for anxiety and general well-being. Of the dietary predictors, folate intake explained the most variance for vitality and for general well-being, 8.6% and 14.2%, respectively.
                A liquid nutrition supplement could be recommended to the elderly when energy maintenance and increases in nutrient intake are necessary and convenience is an important consideration. Dietetics professionals should address the issues of affordability of the supplement, the role of food in achieving nutritional adequacy, and overall quality of life of clients. Folate intake as a predictor of perceived general well-being and vitality requires further investigation. The aim of the study was to assess the effects of micronutrient supplementation on culture conversion in tuberculosis (TB) patients.
                The study was a randomized, double-blind placebo-controlled 2 x 2 trial of zinc and multi-micronutrient (MMN) supplementation in pulmonary TB patients in Tanzania.
                A total of 499 pulmonary TB patients were included in the trial after being confirmed sputum-positive by microscopy or culture. At 8 weeks, 25% were sputum-smear positive but only 11% were culture-positive (P<0.0001). No significant differences were observed in culture conversion rate among those allocated to MMN or placebo (89.5 vs. 86.2%, P=0.29) at 8 weeks, although at week 4 those allocated to MMN had a slightly reduced culture conversion rate (42.8 vs. 52.8%, P=0.058). Zinc had no effects on culture conversion. MMN increased weight gain by 0.78 kg [95% confidence interval (CI): 0.12--1.43] at week 8, while zinc supplementation had no effect. The effects of MMN and zinc did not interact and neither MMN nor zinc interacted with human immunodeficiency virus status, sex and culture-intensity at baseline.
                Neither zinc nor MMN supplementation had significant effects on culture conversion, but MMN supplementation increased weight gain in TB patients. Malnutrition is common in pulmonary tuberculosis (TB), and may impair survival. The objective of this study was to assess effects of multi-vitamin/mineral (MVM) and zinc (Zn) supplementation during TB treatment on mortality. Patients diagnosed with sputum-positive pulmonary TB in Mwanza, Tanzania, were randomised, using a two-by-two factorial design, to Zn (45 mg) or placebo, and MVM (vitamins A, B, C, D, E, and selenium and copper) or placebo. Survival status was ascertained at the end of the 8-month TB treatment and supplementation period. Of 499 TB patients, 213 (43 %) had HIV. The mean weight gain at 7 months was 6.88 kg (95 % CI 6.36, 7.41). Zn and MVM combined, but neither alone (interaction, P=0.03), increased weight gain by 2.37 kg (95 % CI 0.91, 3.83), irrespective of HIV status. Survival status at 8 months was determined for 422 patients (84.6 %), of which fifty-two (12.3 %) had died. Among fifty-two deaths, there were no effects of MVM (relative risk (RR) 0.73; 95 % CI 0.43, 1.23) and Zn (RR 0.76; 95 % CI 0.46, 1.28). However, among HIV co-infected patients, marginally significant effects of both MVM (RR 0.60; 95 % CI 0.34, 1.05) and Zn (RR 0.63, 95 % CI 0.37, 1.08) were seen, and MVM and Zn combined reduced mortality (RR 0.29; 95 % CI 0.10, 0.80; interaction ratio 0.52). In conclusion, supplementation with MVM, including Zn, during treatment of pulmonary TB may reduce mortality in those co-infected with HIV. A randomised trial of the effect of the combined intervention used in this study should be conducted in a different setting to confirm the finding. To compare nutritional counseling with and without oral supplements in HIV-infected patients with recent weight loss.
                Randomized non-blinded controlled trial, stratified for change in antiretroviral treatment at baseline.
                HIV-infected patients with recent weight loss (> 5% of total, and >3% in the last month).
                Nutritional counseling to increase dietary intake by 600 kcal/day over 8 weeks; in group A (n=24) by normal food, and in group B (n=26) by a range of fortified drink supplements with a calorific value of 0.6 to 1.5 kcal/ml.
                Body composition by bioelectrical impedance analysis, dietary intake by 24 h recall.
                Fat free mass increased from baseline to week 8 (P<0.05) with no difference between groups A and B (P=0.97). Body cell mass and weight gain were not significant and equal between groups. Assessed at weeks 2 and 4, group B patients consumed 11 +/- 6 kcal/kg as supplements, and their total energy intake was 6 kcal/kg higher than in group A (P<0.01). Total energy intake was not different between groups at weeks 6 and 8.
                Nutritional counseling and oral supplements are both feasible methods to restore food energy intake in malnourished HIV-infected patients. Although normal food intake is partially replaced, oral supplements may improve the adherence to a weight gain regimen.
                Copyright 1999 Harcourt Publishers Ltd. To evaluate the effects of nutrition counseling with or without oral supplementation in malnourished patients infected with the human immunodeficiency virus (HIV).
                Randomized controlled trial.
                HIV-infected men (n=118) who were less than 90% of usual weight for height or who had lost more than 10% of body weight.
                Nutrition counseling alone (control group) vs nutrition counseling plus enteral supplementation (supplement group) for 6 weeks. All patients were instructed to consume a diet that exceeded estimated total energy expenditure by 960 kcal/day.
                Weight, skinfold thickness, fat-free mass, grip strength, quality of life, and cognitive function (Buschke test).
                Differences in baseline variables and outcomes were evaluated using analysis of variance or the Wilcoxon rank sum test.
                Ninety-nine men completed at least 4 weeks of treatment, 49 in the supplement group and 50 in the control group. Half the patients in each treatment group achieved at least 80% of their energy target. No differences in weight, skinfold thickness measurements, or quality of life were observed. Compared with the control group, the supplement group had larger increases in fat-free mass and grip strength, although the differences did not reach statistical significance.
                In the short term, nutrition counseling with or without oral supplementation can achieve a substantial increase in energy intake in about 50% of malnourished HIV-infected patients. Although further study is needed to evaluate long-term effects, these findings suggest that nutrition counseling has an important role in the management of malnourished HIV-infected patients. 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. To investigate the impact of dietary counseling or nutritional supplements on outcomes in cancer patients: nutritional, morbidity, and quality of life (QoL) during and 3 months after radiotherapy.
                A total of 111 colorectal cancer outpatients referred for radiotherapy, stratified by staging, were randomly assigned: group 1 (G1; n = 37), dietary counseling (regular foods); group 2 (G2; n = 37), protein supplements; and group 3 (G3; n = 37), ad libitum intake. Nutritional intake (diet history), status (Ottery's Subjective Global Assessment), and QoL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0) were evaluated at baseline, at the end, and 3 months after radiotherapy.
                At radiotherapy completion, energy intake increased in G1/G2 (P < or = .04), G1 more than G2 (P = .001), and decreased in G3 (P < .01). Protein intake increased in G1/G2 (P < or = .007), G1 less than G2 (not significant), and decreased in G3 (P < .01). At 3 months, G1 maintained nutritional intake and G2/G3 returned to baseline. After radiotherapy and at 3 months, rates of anorexia, nausea, vomiting, and diarrhea were higher in G3 (P < .05). At radiotherapy completion, in G1 all QoL function scores improved proportionally to adequate intake or nutritional status (P < .05); whereas in G2 only three of six function scores improved proportionally to protein intake (P = .04), and in G3 all scores worsened (P < .05). At 3 months, G1 patients maintained/improved function, symptoms, and single-item scores (P < .02); in G2, only few function and symptom scales improved (P < .05); in G3, QoL remained as poor as after radiotherapy. In G1/G2, respectively, improvement/deterioration of QoL correlated with better or poorer intake or nutritional status (P < .003).
                During radiotherapy, both interventions positively influenced outcomes; dietary counseling was of similar or higher benefit, whereas even 3 months after RT, it was the only method to sustain a significant impact on patient outcomes. To examine whether providing a midmorning nutrition supplement increases habitual energy intake in seniors with probable Alzheimer's disease (AD) and to investigate the effects of body weight status and cognitive and behavioral function on the response to the intervention.
                Randomized, crossover, nonblinded clinical trial.
                A fully accredited geriatric teaching facility affiliated with the University of Toronto's Medical School with a home for the aged.
                Thirty-four institutionalized seniors with probable AD who ate independently.
                Nutrition supplements were provided between breakfast and lunch for 21 consecutive days and compared with 21 consecutive days of habitual intake.
                Investigator-weighed food intake, body weight, cognitive function (Severe Impairment Battery and Global Deterioration Scale), behavioral disturbances (Neuropsychiatric Inventory-Nursing Home Version), and behavioral function (London Psychogeriatric Rating Scale).
                Relative to habitual intake, group mean analyses showed increased 24-hour energy, protein, and carbohydrate intake during the supplement phase, but five of 31 subjects who finished all study phases completely compensated for the energy provided by the supplement by reducing lunch intake, and 24-hour energy intake was enhanced in only 21 of 31 subjects. Compensation at lunch was more likely in subjects with lower body mass indices, increased aberrant motor behavior, poorer attention, and increased mental disorganization/confusion.
                Nutrition supplements were least likely to enhance habitual energy intake in subjects who would normally be targeted for nutrition intervention-those with low body weight status. Those likely to benefit include those with higher body mass indices, less aberrant motor problems, less mental disorganization, and increased attention.
There is insufficient research to know whether routinely providing free food or energy supplements results in better tuberculosis treatment outcomes, or improved quality of life. Further trials, particularly from food insecure settings, should have adequate sample sizes to identify, or exclude, clinically important benefits.
Although blood levels of some vitamins may be low in patients starting treatment for active tuberculosis, there is currently no reliable evidence that routinely supplementing at or above recommended daily amounts has clinical benefits.