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

The goal of this clinical trial was to learn if supplementation with L-carnitine or Coenzyme Q10 improves effectively the oxidative stress markers in adult patients undergoing chronic hemodialysis. It was also to evaluate the basic oxidative profile of hemodialyzed patients and to learn about the safety and tolerability of the two supplements. The main questions it aimed to answer are: * Does tunisian hemodialyzed patients have a severe oxidative status? * Does L-carnitine and Coenzyme Q10 significantly reduce oxidant markers and improve endogenous antioxidants compared to placebo? * Are the positive effects of L-carnitine and Coenzyme Q10 on oxidative stress maintained after a period of wash-out ? * Are L-carnitine and Coenzyme Q10 supplementation safe and well-tolerated in hemodialyzed patients? Researchers had compared the effects of the two supplements to identical placebos. Oxidative parameters were dosed at baseline, after 12 weeks of supplementation, and after 12 weeks of wash-out. Participants had: * taken one of the active molecules or a placebo for 12 weeks. * been followed-up for 12 more weeks of wash-out after the end of the cure. * a monitoring by hebdomadary sheets in each hemodialysis session, that recorded the medication taken the day of the hemodialysis session and the day before, errors and forgetfulness of the medication, as well as any incidents or adverse events, and monthly visits to monitor patient safety, compliance, and collect key clinical data including blood pressure, dry weight, and specific laboratory tests like hemoglobin and thyroid function, all of which were recorded in the Case Report Form (CRF).

NCT Number	NCT07303088
Lead Sponsor	University of Sfax
Conditions	Oxidative Stress Response, Hemodialysis, End Stage Kidney Disease (ESRD)
Enrollment	52 participants
Start Date	2024-06-17
Primary Completion	2024-11-30 (estimated)
Study Completion	2024-11-30 (estimated)
Updated on ClinicalTrials.gov	2025-12-31