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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Disease severity assessment using DAS-28 -CRP — At baseline and after three months. DAS-28-CRP at baseline and at end of study, which will be calculated based on tender joint count (TJC) and swollen joint count (SJC) following the assessment of twenty-eight joints (figure 1) , serum CRP level, and the patient's global health assessment (PGA) on a scale from zero to one hundred. The score will be calculated using the following equation: (CASTREJÓN et al., 2010) DAS-28-CRP = 0.56\* √(TJC28) + 0.28\* √(SJC28) + 0.36\*ln (CRP + 1) +0.014\*(PGA) + 0.96
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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