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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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® ". |
|
| Control group | No Intervention | Group 2 (Control group): consists of 30 patients who will not receive the intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coenzyme Q10 | Drug | Coenzyme Q10 100 mg capsule once daily for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mitochondrial dysfunction | Through assessment of the NLRP3 inflammasome and type 1 IFN (IFN-α). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| systemic lupus erythematosus disease activity index (SLEDAI) score. | Determine its possible beneficial effect on disease activity through assessment of systemic lupus erythematosus disease activity index (SLEDAI) score. | 3 months |
| The safety and tolerability of Coenzyme Q10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Pediatric Allergy, Immunology and Rheumatology Unit, Ain Shams University Hospitals. | Cairo | Egypt |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C024989 | coenzyme Q10 |
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Assess the safety and tolerability of Coenzyme Q10 supplementation in pediatric SLE patients. |
| 3 months |