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

NCT07096557 | Completed Phase 2

• 1 other identifier: RHDIRB2020110301 REC #272
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Mitochondrial dysfunction

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

  3 months

Secondary Outcomes (2)

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

  3 months

• The safety and tolerability of Coenzyme Q10

  3 months

Study Arms (2)

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® ".

Drug: Coenzyme Q10

Control group

NO INTERVENTION

Group 2 (Control group): consists of 30 patients who will not receive the intervention.

Interventions

Coenzyme Q10 DRUG

Coenzyme Q10 100 mg capsule once daily for 3 months

Coenzyme Q10 group

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

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

Cairo, Egypt

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator of clinical pharmacy department at faculty of pharmacy Ain shams university

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: January 1, 2024
• Primary Completion: November 10, 2024
• Study Completion: February 10, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

EG (1)