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

NCT ID: NCT07096557

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-12-31

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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Coenzyme Q10 group

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® ".

Group Type: EXPERIMENTAL

Coenzyme Q10

Intervention Type: DRUG

Coenzyme Q10 100 mg capsule once daily for 3 months

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Coenzyme Q10

Coenzyme Q10 100 mg capsule once daily for 3 months

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Helal

Demonstrator of clinical pharmacy department at faculty of pharmacy Ain shams university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mariam helal kaiser

Role: CONTACT

mariam.helal@pharma.asu.edu.eg

01274712898

Other Identifiers

RHDIRB2020110301 REC #272

Identifier Type: -

Identifier Source: org_study_id