Systemic Lupus ErythematosusPhase 2NCT07096557
The Effect of Co-enzyme Q10 on the Clinical Outcome of Pediatric Patients With Systemic Lupus Erythematosus
A Phase 2 study testing Coenzyme Q10 in people with Systemic Lupus Erythematosus, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the safety and efficacy of coenzyme Q10 supplementation in pediatric patients with SLE. The main questions it aims to answer are: What is the impact of coenzyme Q10 supplementation on mitochondrial dysfunction? Does it have a beneficial effect on disease activity through… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Coenzyme Q10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 10 Feb 2025
- Phase
- Phase 2
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both genders aged 6-16 years old diagnosed with SLE according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria of SLE.
- Patients with moderate to severe activity presenting with lupus nephritis.
Who cannot join
- Patients taking over-the-counter antioxidants such as N-acetylcysteine, vitamin E, omega-3 fatty acids, L-carnitine, or vitamin C.
- Patients with very severe active SLE that might threaten vital organs.
- Patients with chronic infections and severe and recurrent infections, whether bacterial, viral, or fungal infection
Trial locations and contacts
1 site in 1 country.
Egypt1 site
The Pediatric Allergy, Immunology and Rheumatology Unit, Ain Shams University Hospitals.
Cairo
About this study
Official title: Evaluation of the Effect of Co-enzyme Q10 on the Clinical Outcome of Pediatric Patients With Systemic Lupus Erythematosus
The goal of this clinical trial is to evaluate the safety and efficacy of coenzyme Q10 supplementation in pediatric patients with SLE. The main questions it aims to answer are:
- What is the impact of coenzyme Q10 supplementation on mitochondrial dysfunction?
- Does it have a beneficial effect on disease activity through assessment of the systemic lupus erythematosus disease activity index (SLEDAI) score?
Read more
Researchers will compare the group of patients that take coenzyme Q10 to a group that doesn't to see if coenzyme Q10 supplementation works to decrease mitochondrial dysfunction and disease activity.
Participants will:
Take coenzyme Q10 plus the standard treatment of SLE or the standard treatment only every day for 3 months.
Visit the clinic once every 4 weeks for checkups and tests.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Coenzyme Q10
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Drug
Coenzyme Q10 100 mg capsule once daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10 group | Experimental | Group 1 (Coenzyme Q10 group): consists of 30 patients who will receive one capsule containing 100 mg Coenzyme Q10 once daily for 12 weeks, "Coenzyme Q10 Forte® ". Receives: Drug: Coenzyme Q10 |
| Control group | No intervention | Group 2 (Control group): consists of 30 patients who will not receive the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial dysfunction
Through assessment of the NLRP3 inflammasome and type 1 IFN (IFN-α).
Measured: 3 months
Secondary outcomes (2)
systemic lupus erythematosus disease activity index (SLEDAI) score.
Determine its possible beneficial effect on disease activity through assessment of systemic lupus erythematosus disease activity index (SLEDAI) score.
Measured: 3 months
The safety and tolerability of Coenzyme Q10
Assess the safety and tolerability of Coenzyme Q10 supplementation in pediatric SLE patients.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Jan 2024
- Primary completion10 Nov 2024
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helal, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096557
- Sponsor's protocol ID
- RHDIRB2020110301 REC #272
- Status last verified
- Mar 2026
- First submitted
- 24 Jul 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Co-enzyme Q10 on the Clinical Outcome of Pediatric Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07096557
- Acronym / sponsor ID
- RHDIRB2020110301 REC #272
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 31 Jul 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 is to evaluate the safety and efficacy of coenzyme Q10 supplementation in pediatric patients with SLE. The main questions it aims to answer are:
- What is the impact of coenzyme Q10 supplementation on mitochondrial dysfunction?
- Does it have a beneficial effect on disease activity through assessment of the systemic lupus erythematosus disease activity index (SLEDAI) score?
Researchers will compare the group of patients that take coenzyme Q10 to a group that doesn't to see if coenzyme Q10 supplementation works to decrease mitochondrial dysfunction and disease activity.
Participants will:
Take coenzyme Q10 plus the standard treatment of SLE or the standard treatment only every day for 3 months.
Visit the clinic once every 4 weeks for checkups and tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 group | Experimental | Drug: Coenzyme Q10Group 1 (Coenzyme Q10 group): consists of 30 patients who will receive one capsule containing 100 mg Coenzyme Q10 once daily for 12 weeks, "Coenzyme Q10 Forte® ". |
| Control group | No intervention | –Group 2 (Control group): consists of 30 patients who will not receive the intervention. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Both genders aged 6-16 years old diagnosed with SLE according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria of SLE.
- Patients with moderate to severe activity presenting with lupus nephritis.
Key exclusion criteria (3 listed)
- Patients taking over-the-counter antioxidants such as N-acetylcysteine, vitamin E, omega-3 fatty acids, L-carnitine, or vitamin C.
- Patients with very severe active SLE that might threaten vital organs.
- Patients with chronic infections and severe and recurrent infections, whether bacterial, viral, or fungal infection
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 |
|---|---|---|
| Coenzyme Q10Coenzyme Q10 100 mg capsule once daily for 3 months | Drug | Coenzyme Q10 group |
Primary outcome
Mitochondrial dysfunction
Time frame: 3 months
Through assessment of the NLRP3 inflammasome and type 1 IFN (IFN-α).
2 secondary outcomes
systemic lupus erythematosus disease activity index (SLEDAI) score.
Time frame: 3 months
The safety and tolerability of Coenzyme Q10
Time frame: 3 months
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 12 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Coenzyme Q10 in people with Systemic Lupus Erythematosus, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 3 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 12 Mar 2026. 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mitochondrial dysfunction (time frame: 3 months). 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 12 Mar 2026.