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

RECRUITINGPhase 2Sponsored by Ain Shams University
Actively Recruiting
PhasePhase 2
SponsorAin Shams University
Started2024-04-01
Est. completion2025-08-10
Eligibility
Age6 Years – 16 Years
Healthy vol.Accepted

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

Age: 6 Years – 16 YearsHealthy volunteers accepted
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

Conditions2

LupusSystemic Lupus Erythematosus

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