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Completed

NCT Number: NCT07096557

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?

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Pediatric Allergy, Immunology and Rheumatology Unit, Ain Shams University Hospitals.

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coenzyme Q10

Drug

Coenzyme Q10 100 mg capsule once daily for 3 months

Primary outcomes

  1. Mitochondrial dysfunction

    Time frame: 3 months

    Through assessment of the NLRP3 inflammasome and type 1 IFN (IFN-α).

Secondary outcomes

  1. systemic lupus erythematosus disease activity index (SLEDAI) score.

    Time frame: 3 months

    Determine its possible beneficial effect on disease activity through assessment of systemic lupus erythematosus disease activity index (SLEDAI) score.

  2. The safety and tolerability of Coenzyme Q10

    Time frame: 3 months

    Assess the safety and tolerability of Coenzyme Q10 supplementation in pediatric SLE patients.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 31, 2025
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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