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

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)

Interventions

DIETARY_SUPPLEMENT

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.

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.

OTHER

placebo capsules

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

Sponsors & Collaborators

• University of Sfax

  lead OTHER

Principal Investigators

• Lobna Ben Mahmoud, MD, PhD, Medicine professor · University of Sfax

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-17

Primary Completion

2024-11-30

Completion

2024-11-30

Countries

• Tunisia

Study Locations