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The Effect of Nicotinamide on the Clinical Outcome of Rheumatoid Arthritis Patients
RECRUITINGPhase 2Sponsored by Ain Shams University
Actively Recruiting
PhasePhase 2
SponsorAin Shams University
Started2023-12-02
Est. completion2025-06
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06640309
Summary
A randomized controlled interventional study to evaluate the efficacy and safety of nicotinamide supplementation in rheumatoid arthritis patients receiving conventional synthetic disease modifying anti-rheumatic drugs.
Eligibility
Age: 18 Years – 65 YearsHealthy volunteers accepted
Inclusion Criteria: * Adult patients (18-65 years). * Patients with a diagnosis of established rheumatoid arthritis. * Patients presenting with moderate to high disease activity identified as disease activity score-28 based on C-reactive protein levels (DAS-28-CRP) \>3.2. * Receiving stable regimen of one or more conventional disease modifying antirheumatic drugs for at least the past three months. * Patients willing to sign an informed consent. Exclusion Criteria: * Patients with a known history of hypersensitivity or drug allergies to nicotinamide * Patients receiving nicotinamide for any other indications. * Receiving any dosage forms/ dosage regimen of vitamin B3 supplementation * Receiving biologic disease modified antirheumatic drugs therapy. * Impaired liver functions (liver transaminases level ≥ three times upper normal limits). * Impaired kidney functions (estimated glomerular filtration rate (eGFR) \< 30 ml/min) * Pregnancy and lactation. * Patients with other auto-immune diseases.
Conditions2
ArthritisRheumatoid Arthritis
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Actively Recruiting
PhasePhase 2
SponsorAin Shams University
Started2023-12-02
Est. completion2025-06
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06640309