Evaluating nicotinamide's effect on rheumatoid arthritis outcomes
The Effect of Nicotinamide on the Clinical Outcome of Rheumatoid Arthritis Patients
This study is testing if adding nicotinamide to the usual treatment can help people with rheumatoid arthritis feel better over three months.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06640309 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to assess the efficacy and safety of nicotinamide supplementation in patients with rheumatoid arthritis who are already receiving conventional synthetic disease-modifying anti-rheumatic drugs. Participants will be randomly assigned to either a nicotinamide group, receiving a daily dose of 1000mg, or a control group, continuing their standard therapy. The study will evaluate clinical outcomes and disease activity through various assessments, including blood tests and disease activity scores, over a three-month period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with established rheumatoid arthritis and moderate to high disease activity.
Not a fit: Patients with hypersensitivity to nicotinamide, those on biologic therapies, or with significant liver or kidney impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new adjunctive treatment option to improve the quality of life for patients with rheumatoid arthritis.
How similar studies have performed: While the use of nicotinamide in this context is relatively novel, previous studies have explored its benefits in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cairo
- Ain Shams University Hospitals — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Sara A. Raslan, Bachelor
- Email: Sarah.raslan@pharma.asu.edu.eg
- Phone: +20 1020145174
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.