Early Administration of L-carnitine in Hemodialysis Patients

What Was Tested

The trial (phase 3) is built around L-Carnitine.

Hemodialysis is a cause of carnitine deficiency.

It had 1 arm (groups): 1 (experimental).

L-Carnitine.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 110 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: patients with no need of rhuepo; patients with cancer disease; patients with life expectancy under 6 months.

How the Study Was Run

It was run as a randomized, factorial and double-blind study.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2006-06 with completion listed for 2010-06.

It ran at 2 sites in France (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Resistance index to erythropoietin (time frame: during de study).

It also tracked 8 secondary outcomes, for example Acylcarnitine/carnitine ratio measured quarterly, Number of red blood cells transfusion per patient during the study, data collected monthly, 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, Lipid profile, measured quarterly and HbA1c, measured quarterly for diabetic patients and patients with glucose intolerance.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in 110 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.