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

NCT07303088 | Completed

• 1 other identifier: 31/24
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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 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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Oxidative stress parameters

  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.

  T1: Before Treatment; T2: At the end of the 12-week course; T3: After 12 weeks of wash-out

Study Arms (4)

L-carnitine group

ACTIVE COMPARATOR

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.

Dietary Supplement: Oral administration of L-carnitine 1000 Mg

Coenzyme Q10 group

ACTIVE COMPARATOR

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

Dietary Supplement: Oral administration of Coenzyme Q10 300Mg

Placebo group

PLACEBO COMPARATOR

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

Other: placebo capsules

Control group

NO INTERVENTION

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

Interventions

placebo capsules OTHER

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

Placebo group

Oral administration of Coenzyme Q10 300Mg 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.

Also known as: one capsule of 300Mg of Coenzyme Q10

Coenzyme Q10 group

Oral administration of L-carnitine 1000 Mg 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.

Also known as: two capsules of 500Mg of L-carnitine

L-carnitine group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sfax: lead

Study Sites (1)

Social security fund polyclinic

Sfax, Sfax Ville, 3080, Tunisia

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Carnitine; coenzyme Q10

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Lobna Ben Mahmoud, MD, PhD, Medicine professor

  University of Sfax

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Head of hemodialysis unit, Sfax CNSS polyclinic

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: June 17, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: From the date of publication of the article and for a limited duration of 5 years.
• Access Criteria: Qualified researchers and authorized personnel who have received formal approval for a secondary use proposal. They would be able to access relevant study documentation such as the study protocol, the Statistical Analysis Plan (SAP), the informed consent model and the blank Case Report Forms (CRFs).Approved researchers must sign a formal Data Sharing Agreement (DSA) that outlines strict conditions for data usage, prohibiting any attempt to re-identify participants.

Locations

TU (1)