Early Administration of L-carnitine in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00322322
First received: May 3, 2006
Last updated: May 3, 2011
Last verified: March 2007
  Purpose

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.


Condition Intervention Phase
Complication of Hemodialysis
Hyperthyroidism Treated or Under Control
Drug: L-Carnitine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Early Administration of L-carnitine in Hemodialysis Patients: Double Blind Randomized Trial Versus Placebo

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Resistance index to erythropoietin [ Time Frame: during de study ] [ Designated as safety issue: Yes ]
    Resistance index to erythropoietin

  • Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo. [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Haemoglobin level/weekly rHuerythropoietin dose in patients receiving l-carnitine versus those receiving the placebo.


Secondary Outcome Measures:
  • Acylcarnitine/carnitine ratio measured quarterly [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Acylcarnitine/carnitine ratio measured quarterly

  • Number of red blood cells transfusion per patient during the study, data collected monthly [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Number of red blood cells transfusion per patient during the study, data collected monthly

  • Predialysis hypotension per patient during the study, data collected monthly [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Predialysis hypotension per patient during the study, data collected monthly

  • SF 36 physical and total score at inclusion and at the end of the study [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    SF 36 physical and total score at inclusion and at the end of the study

  • Lipid profile, measured quarterly [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Lipid profile, measured quarterly

  • HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance

  • Albuminemia measured quarterly [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Albuminemia measured quarterly

  • c reactive protein measured quarterly [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    c reactive protein measured quarterly


Enrollment: 110
Study Start Date: June 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
L-Carnitine
Drug: L-Carnitine
L-Carnitine
Other Name: L-Carnitine

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with less than 1 month on hemodialysis.
  • Treated with rHuEPO.
  • Male or female aged of more than 18 years old.
  • With contraception treatment for women of procreation age.
  • Having received and understand information.

Exclusion Criteria:

  • Patients with no need of rHuEPO
  • Patients with cancer disease
  • Patients with life expectancy under 6 months
  • Patients having a proved carnitine deficiency before the start of hemodialysis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322322

Locations
France
HOPITAL LA PITIE SALPETRIERE, service de Néphrologie
Paris, France, 75013
Assistance Publique Hopitaux de Paris
Paris, France, 75004
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Lucile Mercadal, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Isabelle BRINDEL, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00322322     History of Changes
Other Study ID Numbers: P050316
Study First Received: May 3, 2006
Last Updated: May 3, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
L-carnitine supplementation
Hemodialysis
Anaemia
Erythropoietin responsiveness

Additional relevant MeSH terms:
Hyperthyroidism
Thyroid Diseases
Endocrine System Diseases
Carnitine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014