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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 16
Healthy Volunteers: t
View:

• 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.

• No enrollment in any other clinical trial.

• Judged by the physician to be physically stable.

Locations
Other Locations
Egypt
The Pediatric Allergy, Immunology and Rheumatology Unit, Ain Shams University Hospitals.
RECRUITING
Cairo
Contact Information
Primary
Mariam helal kaiser
mariam.helal@pharma.asu.edu.eg
01274712898
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 60
Treatments
Experimental: 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® .
No_intervention: Control group
Group 2 (Control group): consists of 30 patients who will not receive the intervention.
Related Therapeutic Areas
Sponsors
Leads: Ain Shams University

This content was sourced from clinicaltrials.gov