NCT00322322

Early Administration of L-carnitine in Hemodialysis Patients

Early Administration of L-carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hemodialysis is a cause of carnitine deficiency. The deficiency of carnitine induces an anemia by an increase fragility of the red blood cells, a muscular fatigue and a cardiac dysfunction. We proposed to evaluate the benefit of an early administration of L-carnitine in hemodialysis patients. The patients should be included in the first month after the start of chronic hemodialysis, randomized to receive L-carnitine or placebo and should be followed-up during one year.

Detailed description

The first aim of the study is to compare the resistance index to erythropoietin (hemoglobin level / rHuerythropoietin dose) with L-carnitine versus placebo Double blind randomized study evaluating the supplementation with L-carnitine versus placebo in patients beginning chronic hemodialysis for less than 1 month. Primary outcome to compare rHuerythropoietin resistance index defined as hemoglobin level / rHuEPO dose ratio with L-carnitine and with placebo. Secondary endpoints to compare acylcarnitine / carnitine ratio, number of red blood cells transfusion, physical status, quality of life, hypotensive episodes, lipid profile, diabetes profile, albuminemia, c reactive protein. Several variables that influenced primary and secondary endpoints will be included in a multivariate analysis; albuminemia, c reactive protein, iron status, dialysis efficiency, protein intake, lipid intake, treatment with additional vitamins (C, B9, B6), treatment with statins, treatment of predialysis hypotension by midodrine, antihypertensive treatments. Statistical analysis: * description of the cohort * comparisons of each evaluated variables between the 2 treatments * ANOVA study for repeated measurements from inclusion to month-12 for Hb / rHuEPO dose to compare the course of the ratio between each group in intention to treat analysis * analysis of the ratio Hb / rHuEPO month by month and taking into account tempera withdrawal Following analysis in both intention to treat and per protocol analysis: * acylcarnitine / carnitine ratio by ANOVA for repeated data * number of predialysis hypotension by Chi2 test * number of red blood cells transfusion by Chi2 test * SF-36 physical status by comparison of mean * SF-36 total score by comparison of mean * lipid profile by ANOVA for repeated data * HbA1c by ANOVA for repeated data * variables that influenced primary and secondary variables will be analyzed by multivariate analysis * statistical study of clinical events per month

Conditions

• Complication of Hemodialysis
• Hyperthyroidism Treated or Under Control

Interventions

Type	Name	Description
DRUG	L-Carnitine	L-Carnitine

Timeline

• Start date: 2006-06-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2006-05-05
• Last updated: 2011-05-04

Locations

2 sites across 1 country: France