CompletedPhase 2

The Effect of Co-enzyme Q10 on the Clinical Outcome of Pediatric Patients With Systemic Lupus Erythematosus

Egypt60 participantsStarted 2024-01-01

Plain-language 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 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.

Who can participate

Age range

6 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mitochondrial dysfunction

Timeframe: 3 months

Trial details

NCT IDNCT07096557

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-10

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