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

NCT ID: NCT07303088

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-17
• Study Completion Date: 2024-11-30

Brief Summary

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 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 event, 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).

Detailed Description

The study design was a prospective, randomized, double-blind 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-carnitine, CoQ10, or placebo) into three groups, using a computer-generated list of random numbers. The target population comprised adult patients aged between 18 and 85 years, with end-stage renal disease, undergoing chronic hemodialysis for more than 6 months, with high-flux dialyzers, and receiving an adequate dialysis dose with satisfactory uremia control. 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. The treatment course lasted 12 weeks and consisted of: (i) L-carnitine group: Two capsules of 500 mg of L-car each, and one placebo capsule identical to Q10; (ii) Coenzyme Q10 group: One capsule of 300 mg of Q10, and two placebo capsules identical to L-car; and (iii) Placebo group: Two placebo capsules identical to L-car and one placebo capsule identical to Q10. Plasma levels of malondialdehyde (MDA), advanced oxidation protein products (AOPP), vitamin C, and glutathione (GSH), as well as the activities of superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (Gpx), were measured in plasma by spectrophotometry before treatment, after the 12-week course, and following a 12-week washout period.

In addition to the study groups, a group of 34 healthy subjects (control group) was collected. The same parameters were measured in this group to evaluate the baseline oxidative status of HD group. The study protocol received approval from the local ethics committee before the initiation of any recruitment.

Conditions

Oxidative Stress Response; Hemodialysis; End Stage Kidney Disease (ESRD)

Keywords

oxidative stress; end stage kidney disease (ESRD); hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

L-carnitine group

L-carnitine group: 18 patients, receiving oral supplementation of 1000Mg of L-carnitine (two capsules of 500 mg of L-carnitine each), and one placebo capsule identical to Coenzyme Q10.

Group Type: ACTIVE_COMPARATOR

Oral administration of L-carnitine 1000 Mg

Intervention Type: DIETARY_SUPPLEMENT

Oral administration of 1000mg of L-carnitine per day ( two oral capsules of 500mg) in L-carnitine group, and one placebo capsule identical to Coenzyme Q10.

Coenzyme Q10 group

Coenzyme Q10 group: 19 patients, receiving one capsule of 300 mg of Q10, and two placebo capsules identical to L-carnitine

Group Type: ACTIVE_COMPARATOR

Oral administration of Coenzyme Q10 300Mg

Intervention Type: DIETARY_SUPPLEMENT

Oral administration of 300mg of Coenzyme Q10 per day (one oral capsule of 300mg) in Coenzyme Q10 group, with two placebo capsules identical to L-carnitine.

Placebo group

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

Group Type: PLACEBO_COMPARATOR

placebo capsules

Intervention Type: OTHER

Oral administration of placebos: Two placebo capsules identical to L-carnitine and one placebo capsule identical to Coenzyme Q10 tablets.

Control group

a group of 34 healthy subjects collected from the regional blood transfusion center, with no systemic or chronic disease.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oral administration of L-carnitine 1000 Mg

Oral administration of 1000mg of L-carnitine per day ( two oral capsules of 500mg) in L-carnitine group, and one placebo capsule identical to Coenzyme Q10.

Intervention Type: DIETARY_SUPPLEMENT

Oral administration of Coenzyme Q10 300Mg

Oral administration of 300mg of Coenzyme Q10 per day (one oral capsule of 300mg) in Coenzyme Q10 group, with two placebo capsules identical to L-carnitine.

Intervention Type: DIETARY_SUPPLEMENT

placebo capsules

Oral administration of placebos: Two placebo capsules identical to L-carnitine and one placebo capsule identical to Coenzyme Q10 tablets.

Intervention Type: OTHER

Other Intervention Names

two capsules of 500Mg of L-carnitine; one capsule of 300Mg of Coenzyme Q10

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• History of Poor medication adherence.
• Severe intercurrent infection.
• Severe hepatocellular insufficiency.
• Major cardiovascular event within 3 months before the study.
• Intake of antioxidants (except vitamin D2 and/or active vitamin D).
• 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.
• Withdrawal of consent.
• Major digestive intolerance/adverse effect during the intervention.
• Severe infection/major cardiovascular event during the study.
• Patient refusal to continue the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sfax

OTHER

Sponsor Role: lead

Responsible Party

Azza KHEDHIRI

Nephrologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lobna Ben Mahmoud, MD, PhD, Medicine professor

Role: STUDY_DIRECTOR

University of Sfax

Locations

Social security fund polyclinic

Sfax, Sfax Ville, Tunisia

Countries

Tunisia

Other Identifiers

31/24

Identifier Type: -

Identifier Source: org_study_id