Effects of L-carnitine and Coenzyme Q10 Supplementation on Oxidative Stress in Tunisian Hemodialysis Patients.

What Was Tested

This registered not phased trial tested L-Carnitine.

It was also to evaluate the basic oxidative profile of hemodialyzed patients and to learn about the safety and tolerability of the two supplements.

It had four arms (groups): L-carnitine group (active comparator), Coenzyme Q10 group (active comparator), Placebo group (placebo comparator) and Control group (no intervention).

Placebo group: 15 patients, receiving two placebo capsules identical to L-carnitine and one placebo capsule identical to Coenzyme Q10.

The registry classes the interventions as dietary supplement and other.

More on the Plan

The study design was a prospective, randomized, double-blind, and placebo-controlled clinical trial, aiming to compare the effects of the two active molecules to identical-looking placebos.

After a visit of pre-selection, elligible Patients were randomly assigned to one of the three intervention groups (L-car, Q10, or placebo), using a computer-generated list of random numbers.

Strict exclusion criteria included patients' history of poor medication adherence, severe intercurrent infection, hepatocellular failure, or a recent major cardiovascular event, or those receiving antioxidant treatment within one to six months before the study, depending on the type of antioxydant.

In addition to the study groups, a group of 34 healthy subjects (control group) was collected.

Who Took Part

The registry lists 52 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Patients on chronic hemodialysis for at least 6 months. Age between 18 and 85 years old. Chronic hemodialysis performed 3 times per week with high-flux dialyzers. Satisfactory control of uremia. Life expectancy greater than 1 year.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: history of poor medication adherence; severe intercurrent infection; severe hepatocellular insufficiency.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

The L-Carnitine group and the comparison group ran side by side rather than switching.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-06-17 with completion listed for 2024-11-30.

It ran at 1 site in Tunisia.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Oxidative stress parameters (time frame: T1: Before Treatment; T2: At the end of the 12-week course; T3: After 12 weeks of wash-out).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 52 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.