title: CONSORT for Reporting Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration Results of a single blind, randomized, placebo-controlled clinical trial to study the effect of intravenous L-carnitine supplementation on health-related quality of life in Indian patients on maintenance hemodialysis. Effects of Oral L-Carnitine Supplementation on Lipid Profile, Anemia, and Quality of Life in Chronic Renal Disease Patients under Hemodialysis: A Randomized, Double-Blinded, Placebo-Controlled Trial Oral carnitine supplementation for dyslipidemia in chronic hemodialysis patients. L-carnitine infusions may suppress serum C-reactive protein and improve nutritional status in maintenance hemodialysis patients. Effects of Oral L-Carnitine Supplementation on Leptin and Adiponectin Levels and Body Weight of Hemodialysis Patients: a Randomized Clinical Trial. Intravenous L-carnitine increases plasma carnitine, reduces fatigue, and may preserve exercise capacity in hemodialysis patients. Quality of life during and between hemodialysis treatments: role of L-carnitine supplementation. Nutritional effects of carnitine supplementation in hemodialysis patients. Potential inhibitory effects of L-carnitine supplementation on tissue advanced glycation end products in patients with hemodialysis.
abstract: Background Clear , transparent , and sufficiently detailed abstract s of conferences and journal articles related to r and omized controlled trials ( RCTs ) are important , because readers often base their assessment of a trial solely on information in the abstract . Here , we extend the CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement to develop a minimum list of essential items , which authors should consider when reporting the results of a RCT in any journal or conference abstract . Methods and Findings We generated a list of items from existing quality assessment tools and empirical evidence . A three-round , modified-Delphi process was used to select items . In all , 109 participants were invited to participate in an electronic survey ; the response rate was 61 % . Survey results were presented at a meeting of the CONSORT Group in Montebello , Canada , January 2007 , involving 26 participants , including clinical trialists , statisticians , epidemiologists , and biomedical editors . Checklist items were discussed for eligibility into the final checklist . The checklist was then revised to ensure that it reflected discussion s held during and subsequent to the meeting . CONSORT for Abstract s recommends that abstract s relating to RCTs have a structured format . Items should include details of trial objectives ; trial design ( e.g. , method of allocation , blinding/masking ) ; trial participants ( i.e. , description , numbers r and omized , and number analyzed ) ; interventions intended for each r and omized group and their impact on primary efficacy outcomes and harms ; trial conclusions ; trial registration name and number ; and source of funding . We recommend the checklist be used in conjunction with this explanatory document , which includes examples of good reporting , rationale , and evidence , when available , for the inclusion of each item . Conclusions CONSORT for Abstract s aims to improve reporting of abstract s of RCTs published in journal articles and conference proceedings . It will help authors of abstract s of these trials provide the detail and clarity needed by readers wishing to assess a trial 's validity and the applicability of its results BACKGROUND Carnitine insufficiency is responsible for various co-morbid conditions in maintenance hemodialysis ( MHD ) patients .  L-carnitine supplementation is expected to improve the quality of life ( QoL ) of patients on MHD . AIMS To study the effect of L-carnitine supplementation on QoL of Indian patients on MHD . SETTING AND DESIGN This was a single ( patient ) blind , r and omized , placebo-controlled clinical trial conducted on patients on MHD attending hemodialysis unit of the study center . MATERIAL S AND METHODS Twenty patients on MHD suffering from hemodialysis-related symptoms were r and omly assigned to receive intravenous L-carnitine 20 mg/kg or placebo after every dialysis session for 8 weeks . SF36 ( Short Form with 36 questions ) score for QoL , laboratory investigations and dialysis related symptoms were recorded at baseline and after 8 weeks . Improvement in QoL , laboratory parameters and dialysis related symptoms in the two groups after 8 weeks was compared . STATISTICAL ANALYSIS USED Depending on normality of data , unpaired T test or Mann Whitney U test was used for comparison of change ( 8 weeks-baseline ) in SF36 scores and laboratory parameters observed in the two groups . RESULTS L-carnitine supplementation increased total SF36 score by 18.29 + /- 12.71 ( 95 % CI : 10.41 to 26 ) while placebo result ed in reduction in total SF36 score by 6.4 + /- 16.39 ( 95 % CI : -16.59 to 3.73 ) . L-carnitine also result ed in significant increase in hemoglobin and serum albumin and decrease in serum creatinine as compared to placebo . More patients were relieved of dialysis related symptoms in L-carnitine group . CONCLUSION Intravenous L-carnitine supplementation improves QoL in patients on MHD In patients on maintenance hemodialysis several factors reduce the body stored carnitine which could lead to dyslipidemia , anemia , and general health in these patients . We evaluated the effect of oral L-carnitine supplementation on lipid profiles , anemia , and quality of life ( QOL ) in hemodialysis patients . In a r and omized , double-blinded , placebo-controlled trial , end-stage renal disease ( ESRD ) patients on hemodialysis received either L-carnitine 1 g/d ( n = 24 ) or placebo ( 27 patients ) for 16 weeks . At the end of the study , there was a significant decrease in triglyceride ( −31.1 ± 38.7 mg/dL , P = 0.001 ) and a significant increase in HDL ( 3.7 ± 2.8 mg/dL , P < 0.001 ) levels in the carnitine group . Decrease in total cholesterol ( −6.6 ± 16.0 mg/dL , P = 0.075 ) and increase in hemoglobin ( 0.7 ± 1.7 g/dL , P = 0.081 ) concentrations in the carnitine group were not significant . There was no statistically significant changes in LDL in any group ( P > 0.05 ) . Erythropoietin dose was significantly decreased in both the carnitine ( −4750 ± 5772 mg , P = 0.001 ) and the placebo group ( −2000 ± 4296 mg , P < 0.05 ) . No improvement was observed in QOL scores of two groups . In ESRD patients under maintenance hemodialysis  , oral L-carnitine supplementation may reduce triglyceride and cholesterol and increase HDL and hemoglobin and subsequently reduce needed erythropoietin dose without effect on QOL Carnitine deficiency is a commonly observed problem in maintenance hemodialysis ( MHD ) patients , which results in altered metabolism of fatty acids and subsequently development of dyslipidemia . To evaluate the effect of oral L-carnitine ( LC ) supplementation on lipid profile of adult MHD patients , we studied 30 of them ( 19 males , 11 females ) who received LC supplementation of 250 mg tablets three times a day for eight weeks . They were compared with 30 matched patients as a control group . Serum lipid profiles were compared before and after the intervention between the two groups . There was a significant decrease of the values of the lipid profile in the intervention group before and after carnitine supplementation including the mean values of total cholesterol ( 190 ± 36.8 vs. 177 ± 31.2 mg/dL ) , triglyceride ( 210 ± 64.7 vs. 190 ± 54.1 mg/dL ) and LDL-cholesterol ( 117 ± 30.1 vs. 106 ± 26.3 mg/dL ) , while the values did not change siginificantly from base line in the control group . However , the difference for HDL-cholesterol in intervention group was not statistically significant . None of the patients dropped out of the study due to drug side effects  . Oral LC supplementation ( 750 mg/day ) is able to improve lipid profile in patients on MHD . Further long-term studies with adequate sample size are needed to define the population of patients who would benefit more from carnitine therapy and the optimal dose and the most efficient route for administration of the drug Scattered reports indicate that L-carnitine may suppress proinflammatory cytokines in sick individuals without renal disease and may improve protein synthesis or nitrogen balance either in patients without renal disease or in maintenance hemodialysis ( MHD ) or chronic peritoneal dialysis patients . We conducted an experimental study in MHD patients to evaluate the effects of L-carnitine treatment on inflammatory and protein-energy nutritional status .  MHD patients were assigned to receive intravenous injections of L-carnitine 20 mg/kg ( n = 48 ) or placebo ( n = 65 ) thrice weekly at the end of each hemodialysis treatment for 6 months . The carnitine-treated group showed a statistically significant decrease in serum C-reactive protein and increase in serum albumin and transferrin , blood hemoglobin , and body mass index . Conversely , in the placebo-treated group , a significant decrease was reported for serum albumin , serum transferrin , and body mass index , whereas the other considered measures did not change significantly . These preliminary findings suggest that in MHD patients , L-carnitine therapy may suppress inflammation , particularly among those patients with C-reactive protein > or =3 mg/dL , and may improve protein-energy nutritional status INTRODUCTION Carnitine supplementation may improve the general health and quality of life of hemodialysis patients by improving adipokines levels . The aim of the study was to investigate the effects of L-carnitine supplementation on leptin levels , adiponectin levels , and body weight of hemodialysis patients . MATERIAL S AND METHODS Fifty hemodialysis patients were r and omly divided into the carnitine group , who received oral L-carnitine , 1 g/L for 3 months , and the control group . Anthropometric measurements and serum levels of adipokines were measured at baseline and at the end of the intervention . RESULTS Forty-two participants completed the study . Serum leptin concentrations decreased after 12 weeks of the intervention in both groups , but these changes were not significant . The mean change of leptin concentration were , -1.7 ± 19.0 µg/mL and -7.1 ± 20.0 µg/mL in the carnitine group and the control group , respectively ( P = .39 ) . The mean adiponectin levels at baseline and after the intervention were 8.6 ± 11.19 µg/mL and 9.8 ± 4.1 µg/mL in the carnitine group ( P = .67 ) and 5.0 ± 2.5 µg/mL and 11.2 ± 5.4 µg/mL in the control group , respectively ( P < .001 ) . Serum adiponectin levels increased significantly in the control group only . The decrease in body mass index was not significant . CONCLUSIONS This study showed that a daily supplementation of 1000 mg oral syrup of L-carnitine for 12 weeks did not affect leptin and adiponectin levels or the body weight or body mass index of hemodialysis patients Exercise capacity in patients with end-stage renal disease ( ESRD ) remains impaired despite correction of anemia . Carnitine insufficiency may contribute to impaired exercise and functional capacities in patients with ESRD . Two r and omized placebo-controlled trials were conducted to test whether intravenous L-carnitine improves exercise capacity ( assessed by maximal rate of oxygen consumption [ VO(2max ) ] ) and quality of life ( measured by the Kidney Disease Question naire [ KDQ ] ) in patients with ESRD . In study A , patients were administered L-carnitine , 20 mg/kg ( n = 28 ) , or placebo ( n = 28 ) intravenously at the conclusion of each thrice-weekly dialysis session for 24 weeks . In study B , a dose-ranging study , patients were administered intravenous L-carnitine , 10 mg/kg ( n = 32 ) , 20 mg/kg ( n = 30 ) , or 40 mg/kg ( n = 32 ) , or placebo ( n = 33 ) as in study A. The prospect i ve primary statistical analysis evaluated changes in VO(2max ) in each study and specified that changes in the KDQ were assessed only in the combined population s. L-Carnitine supplementation increased plasma carnitine concentrations , but did not affect VO(2max ) in either study . Because change in VO(2max ) showed significant heterogeneity , a secondary analysis using a mixture of linear models approach on the combined study population s was performed . L-Carnitine therapy ( combined all doses ) was associated with a statistically significant smaller deterioration in VO(2max ) ( -0.88 + /- 0.26 versus -0.05 + /- 0.19 mL/kg/min , placebo versus L-carnitine , respectively ; P = 0.009 ) . L-Carnitine significantly improved the fatigue domain of the KDQ after 12 ( P = 0.01 ) and 24 weeks ( P = 0.03 ) of treatment compared with placebo using the primary analysis but did not significantly affect the total score ( P = 0.10 ) or other domains of the instrument ( P > 0.11 ) . Carnitine was well tolerated , and no drug-related adverse effects were identified . Intravenous L-carnitine treatment increased plasma carnitine concentrations , improved patient-assessed fatigue , and may prevent the decline in peak exercise capacity  in hemodialysis patients .  VO(2max ) in the primary analysis and other assessed end points were unaffected by carnitine therapy End-stage renal disease affects every aspect of a patient 's life , including perception of health and quality of life . It is likely that a hemodialysis patient 's perceptions of health-related quality of life directly influence compliance with medical , nursing , and nutritional prescriptions . Because L-carnitine supplementation is known to enhance muscle strength and energy in hemodialysis patients , we hypothesized that L-carnitine supplementation would enhance a hemodialysis patient 's perception of health-related quality of life . To test this hypothesis , 1 g L-carnitine or placebo was administered orally to 101 patients immediately before and after every hemodialysis treatment for 6 months . To assess health-related quality of life from the patient 's perspective , the Medical Outcomes Study Short Form 36 instrument was administered before the study and at 1.5-month intervals for the duration of the study . In addition , a 10-item question naire design ed to assess common intradialytic symptoms was administered at the end of each dialysis treatment . Other parameters analyzed included Kt/V(urea ) and level of nutrition . In the 6-month group , oral L-carnitine supplementation had an early positive effect on general health ( P < 0.02 ) and physical function ( P < 0.03 ) , but the perceived effect was not sustained throughout the 6 months of the study . In the 3-month group , L-carnitine supplementation improved vitality ( P < 0.02 ) and general health ( P < 0.01 ) . There was no association between Kt/V(urea ) and perceived health-related quality of life . Serum albumin concentration was directly correlated to how patients perceived the quality of their lives AIMS Carnitine is involved in fatty acid metabolism and it is cleared by dialysis . As it plays a role in energy utilization and because malnutrition is a frequent complication of HD treatment , we studied the effects of carnitine supplementation on several nutritional parameters in HD patients . MATERIAL AND METHODS The main selection criterion was a body mass index ( BMI ; body weight/(height)2 ) < 22 kg/m2 . Fifty-three patients were enrolled to participate in this open and r and omized study . For 6 months , 28 patients received 15 mg/kg of intravenous L-carnitine at the end of each  hemodialysis ( HD ) treatment  ( Group A ) , the remaining 25 patients were controls ( Group B ) . The measured parameters were the post-dialysis body weight , serum albumin concentration ( nephelemetry ) , food intake assessed by a 3-day food question naire , nPNA ( normalized protein equivalent of nitrogen appearance ) , creatinine generation , and anthropometry . RESULTS Forty-five patients completed the study ( Group A : 14 F/9 M , 66.7 years old ; Group B : 11 F/11 M , 65.2 years old ) . At the beginning of the study , there were no differences between the groups for age , gender , HD duration , BMI , diabetes prevalence , plasma carnitine levels and measured nutritional parameters . 65.2 % and 77.3 % in each group were carnitine-deficient ( plasma total carnitine level < 35 micromol/l ) . After 6 months of L-carnitine supplementation , none of the nutritional parameters had changed in either group , except that serum albumin concentration decreased in both groups . Dividing each group according to their respective median serum albumin concentrations , daily energy and protein intakes , creatinine generation or triceps skinfold thickness did not show any difference in the various nutritional parameters with or without carnitine supplementation . CONCLUSION Carnitine supplementation , despite normalization of plasma carnitine levels , has no effect on the nutritional status of HD patients BACKGROUND AND AIMS Advanced glycation end products ( AGEs ) contribute to cardiovascular disease in patients with hemodialysis ( HD ) . We have recently found that carnitine levels are inversely associated with skin AGE levels in HD patients . We examined whether L-carnitine supplementation reduced skin AGE levels in HD patients with carnitine deficiency . METHODS This was a single-center study . One hundred and two HD patients ( total carnitine levels < 50 μmol/L ) were enrolled and r and omized to either oral administration of L-carnitine ( 900 mg/day ) ( n=51 ) or control ( n=51 ) . After 6 months , metabolic and inflammatory variables , including serum levels of carnitine , were measured . Skin AGE levels were determined by evaluating skin auto-fluorescence with an AGE-reader . RESULTS There were no significant differences of clinical variables at baseline between the  control and L-carnitine therapy group . Thirty-two patients did not complete the assessment or treatment of the study .  Oral L-carnitine supplementation for 6 months significantly increased low-density lipoprotein cholesterol ( LDL-C ) , triglycerides , total , free , and acyl carnitine levels , while it decreased alanine transaminase , acyl/free carnitine ratio , β₂-microglobulin , and skin AGE values . Change in total carnitine values from baseline ( Δtotal carnitine ) and Δfree carnitine were inversely associated with Δskin AGE levels  in L-carnitine-treated patients ( p=0.036 and p=0.016 , respectively ) . In multiple regression analysis , Δfree carnitine was a sole independent determinant of Δskin AGEs ( R²=0.178 ) . CONCLUSIONS The present study demonstrated that oral L-carnitine supplementation significantly decreased skin AGE levels in HD patients with carnitine deficiency . These observations suggest that supplementation of L-carnitine might be a novel therapeutic strategy for preventing the accumulation of tissue AGEs in carnitine-deficient patients with HD
target: Having this evidence s , the potential role of Carnitine in improving malnutrition consequences in CKD patients would be clearly defined
background: Protein energy malnutrition is a common problem in patients with chronic kidney disease ( CKD ) .
  Scattered reports indicate that supplementation of Carnitine may improve patients ' clinical symptoms , with significant improvement in nutritional parameters .
  This systematic review was done to document the evidence s of Carnitine effects in nutritional status of CKD patients .