Status and phase
Conditions
Treatments
About
This is a study designed to test the hypothesis that treatment with L-carnitine will improve the quality of life and some specific symptoms and signs in patients with renal failure submitted to hemodialysis.
Full description
L-Carnitine is a naturally occurring compound that facilitates the transport of fatty acids into mitochondria for beta-oxidation. A lack of carnitine in hemodialysis patients is caused by insufficient carnitine synthesis and particularly by the loss through dialytic membranes, leading in some patients to carnitine depletion with a relative increase of esterified forms. Many studies have shown that L-carnitine supplementation leads to improvements in several complications seen in uremic patients, including cardiac complications, impaired exercise and functional capacities, muscle symptoms, increased symptomatic intradialytic hypotension, and erythropoietin-resistant anemia, normalizing the reduced carnitine palmitoyl transferase activity in red cells.
Sex
Ages
Volunteers
Inclusion criteria
Patients with the following criteria will be eligible for participation in this study:
Male or female adults over 18 years of age
On hemodialysis for at least one year
Interdialysis weight gain < 5%
Bicarbonate dialysis 3 times per week
Modality of dialysis unchanged for 3 months prior to entry into the study (concerning dialysis-time and mode: bicarbonate, acetate dialysis)
Have one of the following symptoms and signs that have not responded to diet or pharmacological intervention:
On regular treatment with vitamin B12 and folates
Normal iron status (ferritin > 100 ng/ml; transferrin saturation [TSAT] > 20%)
Informed consent obtained
Patients with diabetes mellitus are allowed to enter the study if they have stable glycaemic control on diet or pharmacological treatment.
Exclusion criteria
Patients displaying one or more of the following criteria will not be eligible for participation in this study:
Primary purpose
Allocation
Interventional model
Masking
Loading...
Central trial contact
Kwan-Dun Wu, Ph.D
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal