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Coenzyme Q10 in Juvenile Idiopathic Arthritis Patients

NCT05871086 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-05-31

No results posted yet for this study

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.

Conditions

  • Juvenile Idiopathic Arthritis

Interventions

DIETARY_SUPPLEMENT

Coenzyme Q10

Coenzyme Q10 soft gelatin capsules daily for 3 months

OTHER

Placebo

Placebo Capsules

DRUG

Standard Regimen

Patients may be receiving any of these commonly used JIA treatments including: * Ibuprofen - 30 to 40 mg/kg/day in 3 to 4 divided doses * Diclofenac - 2 to 3 mg/kg/day in divided doses 2 to 3 times daily * Methotrexate - Initial: 10 to 15 mg/m2 once weekly; adjust gradually up to 20 to 30 mg/m2 once weekly * Leflunomide - Weight based, 10-20 mg once daily * Sulfasalazine - 30 to 50 mg/kg/day in 2 divided doses * Etanercept - 0.8 mg/kg/dose once weekly * Adalimumab - Weight based, 10-40 mg every other week

Sponsors & Collaborators

  • Nourhan Elsherif

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05871086 on ClinicalTrials.gov