drugset / Trial / NCT05871086

Coenzyme Q10 in Juvenile Idiopathic Arthritis Patients

NCT05871086

Phase 2/3 Unknown 60 enrolled Nourhan Elsherif
RandomizedParallel-groupSingle-blindTreatment

Summary

Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatological disorder in childhood of unknown cause and a major cause of functional disability. Standard JIA treatment including nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, methotrexate, and biological agents have considerable adverse effects in addition to their high cost. Despite the success of these treatment approaches, patients may still have active disease with other sequelae from chronic inflammation and considerable morbidity that may negatively impact patients' quality of life. Therefore, evaluating the potential benefit of alternative add-on anti-inflammatories and antioxidants might be a promising area for further research. Coenzyme Q10 (CoQ10) is a natural mitochondrial electron carrier and a powerful lipophilic antioxidant located in almost all cell membranes and plasma lipoproteins. Several preclinical studies in animal models as well as clinical trials in adult patients with rheumatoid arthritis (RA) have demonstrated the beneficial effects of CoQ10. Results show that CoQ10 can reduce the oxidative and inflammatory status as well as clinical features that characterize this systemic autoimmune disease. Also, CoQ10 has been used safely in children before and was well tolerated. Thus, the investigators would like to evaluate the effect of CoQ10 oral supplementation in pediatric JIA patients.

Timeline

Start
2023-05-01
Primary completion
2023-12
Completion
2023-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Coenzyme Q10 Other / unclassified 100 mg Oral
Background Adalimumab Monoclonal antibody 10 mg
Background Adalimumab Monoclonal antibody 40 mg
Background Diclofenac Other / unclassified 2 mg/kg
Background Diclofenac Other / unclassified 3 mg/kg
Background Etanercept Protein / enzyme biologic 0.8 mg/kg
Background Ibuprofen Small molecule 30 mg/kg
Background Ibuprofen Small molecule 40 mg/kg
Background Leflunomide Small molecule 10 mg
Background Leflunomide Small molecule 20 mg
Background Methotrexate Small molecule 10 mg/m2
Background Methotrexate Small molecule 15 mg/m2
Background Methotrexate Small molecule 20 mg/m2
Background Methotrexate Small molecule 30 mg/m2
Background Sulfasalazine Small molecule 30 mg/kg
Background Sulfasalazine Small molecule 50 mg/kg