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

Not Applicable

Recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Coenzyme Q10

• Registration Number: NCT07096557
• Lead Sponsor: Ain Shams University

Brief Summary

The goal of this clinical trial is to evaluate the efficacy and safety of coenzyme Q10 supplementation in pediatric patients with SLE. The main questions it aims to answer are:

* What the impact of coenzyme Q10 supplementation on mitochondrial dysfunction?

* Does it have beneficial effect on disease activity through assessment of 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31
• Primary Completion: 2025-08-10
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Both genders aged 6-16 years old diagnosed with SLE according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria of SLE.
2. Patients with moderate to severe activity presenting with lupus nephritis.
3. No enrollment in any other clinical trial.
4. Judged by the physician to be physically stable.

Exclusion Criteria

1. Patients taking over-the-counter antioxidants such as N-acetylcysteine, vitamin E, omega-3 fatty acids, L-carnitine or vitamin C that can enhance the effect of CoQ10.
2. Patients with very severe active SLE that might threaten vital organs.
3. Patients with chronic infections, severe and recurrent infections whether bacterial, viral, or fungal infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coenzyme Q10 group	Coenzyme Q10	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® ".

Primary Outcome Measures

Name	Time	Method
Mitochondrial dysfunction	3 months	Through assessment of NLRP3 Inflammasome and Type 1 INF (INF α).

Secondary Outcome Measures

Name	Time	Method
systemic lupus erythematosus disease activity index (SLEDAI) score.	3 months	Determine its possible beneficial effect on disease activity through assessment of systemic lupus erythematosus disease activity index (SLEDAI) score.
The safety and tolerability of Coenzyme Q10	3 months	Assess the safety and tolerability of Coenzyme Q10 supplementation in pediatric SLE patients.

Trial Locations

Locations (1)

The Pediatric Allergy, Immunology and Rheumatology Unit, Ain Shams University Hospitals.; 🇪🇬 Cairo, Egypt