Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT06640309

The Effect of Nicotinamide on the Clinical Outcome of Rheumatoid Arthritis Patients

Led by Ain Shams University · Updated on 2024-10-16

70

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Effect of Nicotinamide on the Clinical Outcome of Rheumatoid Arthritis Patients

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Patients with a known history of hypersensitivity or drug allergies to nicotinamide.
  • Patients receiving nicotinamide for any other indications.
  • Receiving any dosage forms or 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ain Shams University Hospitals

Cairo, Egypt

Actively Recruiting

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Research Team

S

Sara A. Raslan, Bachelor

CONTACT

D

Dalia Abdelmohsen, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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The Effect of Nicotinamide on the Clinical Outcome of Rheumatoid Arthritis Patients | DecenTrialz