NCT07303088Completed
Effects of L-carnitine and Coenzyme Q10 Supplementation on Oxidative Stress in Tunisian Hemodialysis Patients.
Effects of L-Carnitine and Coenzyme Q10 Supplementation on Oxidative Stress in Tunisian Hemodialysis Patients: The L-Car-Q10 Study-A Randomized Clinical Trial.
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 11 Dec 2025
- Start date
- 17 Jun 2024
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- University of Sfax
- Diseases
- Chronic kidney disease
- NCT number
- NCT07303088
What you commit to
- Study type: Interventional
- Participants enrolled: 52
- From 17 Jun 2024 to the primary completion date, 30 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major cardiovascular event within 3 months before the study.
- Intake of vitamins E, D3, or B9 → Washout period of at least 1 month.
- Intake of L-car, other amino acids, or CoQ10 → Washout period of at least 6 months.
Other illness
- History of Poor medication adherence.
- Severe intercurrent infection.
- Severe hepatocellular insufficiency.
- Severe infection/major cardiovascular event during the study.
Other
- Intake of antioxidants (except vitamin D2 and/or active vitamin D).
- Withdrawal of consent.
- Major digestive intolerance/adverse effect during the intervention.
- Patient refusal to continue the trial.
Who the study is looking for
- 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.
- Adequate dialysis dose : PRU ≥ 65% and/or KT/V \> 1.1.
- Satisfactory control of uremia.
- Life expectancy greater than 1 year.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Social security fund polyclinic Coordinator of this site? Confirm its status | Sfax | Tunisia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.