Oxidative Stress ResponseL-car-Q10NCT07303088
Effects of L-carnitine and Coenzyme Q10 Supplementation on Oxidative Stress in Tunisian Hemodialysis Patients.
A study testing Oral administration of L-carnitine 1000 Mg and Oral administration of Coenzyme Q10 300Mg in people with Oxidative Stress Response and Hemodialysis, run by University of Sfax at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Oxidative Stress Response, Hemodialysis, End Stage Kidney Disease (ESRD)
- What is being tested?
- Oral administration of L-carnitine 1000 Mg and Oral administration of Coenzyme Q10 300Mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTunisia
- Study dates
- 17 Jun 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of L-Carnitine and Coenzyme Q10 Supplementation on Oxidative Stress in Tunisian Hemodialysis Patients: The L-Car-Q10 Study-A Randomized Clinical Trial.
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?
Read more
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).
Read the detailed description
The study design was a prospective, randomized, double-blind, and placebo-controlled 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-car, Q10, or placebo), 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.
- Being tested
- Oral administration of L-carnitine 1000 Mg, Oral administration of Coenzyme Q10 300Mg, placebo capsules
- Keywords
- oxidative stress, end stage kidney disease (ESRD), hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral administration of L-carnitine 1000 MgDietary supplement
Also called two capsules of 500Mg of L-carnitine
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.
Oral administration of Coenzyme Q10 300MgDietary supplement
Also called one capsule of 300Mg of Coenzyme Q10
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 capsulesOther
Oral administration of placebos: Two placebo capsules identical to L-carnitine and one placebo capsule identical to Coenzyme Q10 tablets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T1: Before Treatment; T2: At the end of the 12-week course; T3: After 12 weeks of wash-out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start17 Jun 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative Stress ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sfax
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azza KHEDHIRI, University of Sfax
- Investigators
- Lobna Ben Mahmoud, MD, PhD, Medicine professor, Study director, University of Sfax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303088
- Sponsor's protocol ID
- 31/24
- Acronym
- L-car-Q10
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw results of the various measured parameters in Excel files, the informed consent model, the CRF model, and the follow-up sheets models, once the article is officially accepted for publication. The datasets analyzed during the study are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of L-Carnitine and Coenzyme Q10 Supplementation on Oxidative Stress in Tunisian Hemodialysis Patients: The L-Car-Q10 Study-A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07303088
- Acronym / sponsor ID
- L-car-Q10 / 31/24
- Keywords
- oxidative stress, end stage kidney disease (ESRD), hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of SfaxUniversity, hospital or other
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study design was a prospective, randomized, double-blind, and placebo-controlled 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-car, Q10, or placebo), 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| L-carnitine group | Active comparator | Dietary Supplement: Oral administration of L-carnitine 1000 MgL-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. |
| Coenzyme Q10 group | Active comparator | Dietary Supplement: Oral administration of Coenzyme Q10 300MgCoenzyme Q10 group: 19 patients, receiving one capsule of 300 mg of Q10, and two placebo capsules identical to L-carnitine |
| Placebo group | Placebo comparator | Other: placebo capsulesPlacebo group: 15 patients, receiving two placebo capsules identical to L-carnitine and one placebo capsule identical to Coenzyme Q10 |
| Control group | No intervention | –a group of 34 healthy subjects collected from the regional blood transfusion center, with no systemic or chronic disease. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral administration of L-carnitine 1000 MgAlso: two capsules of 500Mg of L-carnitineOral 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 | L-carnitine group |
| Oral administration of Coenzyme Q10 300MgAlso: one capsule of 300Mg of Coenzyme Q10Oral 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. | Dietary supplement | Coenzyme Q10 group |
| placebo capsulesOral administration of placebos: Two placebo capsules identical to L-carnitine and one placebo capsule identical to Coenzyme Q10 tablets. | Other | Placebo group |
Primary outcome
Oxidative stress parameters
Time frame: T1: Before Treatment; T2: At the end of the 12-week course; T3: After 12 weeks of wash-out
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Yes. Raw results of the various measured parameters in Excel files, the informed consent model, the CRF model, and the follow-up sheets models, once the article is officially accepted for publication. The datasets analyzed during the study are available from the corresponding author on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lobna Ben Mahmoud, MD, PhD, Medicine professor study director
University of Sfax
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral administration of L-carnitine 1000 Mg and Oral administration of Coenzyme Q10 300Mg in people with Oxidative Stress Response and Hemodialysis, run by University of Sfax at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative stress parameters (time frame: T1: Before Treatment; T2: At the end of the 12-week course; T3: After 12 weeks of wash-out). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.