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

NCT06640309 | Recruiting Phase 2

• 1 other identifier: NAM/RA/1223
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Nicotinamide; Quality of life; DAS-28

Outcome Measures

Primary Outcomes (1)

• Disease severity assessment using DAS-28 -CRP

  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

  At baseline and after three months.

Secondary Outcomes (4)

• Serum Interleukin-10

  At baseline and after three months.

• Detection of any change in inflammatory markers

  At baseline and after three months.

• Quality of Life (QOL) questionnaire

  At baseline and after three months.

• Safety and tolerability of Nicotinamide

  Three months.

Study Arms (2)

Nicotinamide group

EXPERIMENTAL

Patients will receive nicotinamide 1000mg tablet once daily.in addition to their conventional therapy for three months.

Drug: Nicotinamide Tablet; Drug: conventional synthetic antirheumatic drugs

control group

ACTIVE COMPARATOR

Patients will receive their conventional therapy only.

Drug: conventional synthetic antirheumatic drugs

Interventions

Nicotinamide Tablet DRUG

Nicotinamide is anti-inflammatory and antioxidant.

Nicotinamide group

conventional synthetic antirheumatic drugs DRUG

methotrexate- leflunomide- sulfasalazine- hydroxychloroquine

Nicotinamide group; control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

RECRUITING

Related Publications (3)

• Kamat JP, Devasagayam TP. Nicotinamide (vitamin B3) as an effective antioxidant against oxidative damage in rat brain mitochondria. Redox Rep. 1999;4(4):179-84. doi: 10.1179/135100099101534882.

  PMID: 10658823 BACKGROUND

• Miesel R, Kurpisz M, Kroger H. Modulation of inflammatory arthritis by inhibition of poly(ADP ribose) polymerase. Inflammation. 1995 Jun;19(3):379-87. doi: 10.1007/BF01534394.

  PMID: 7628865 BACKGROUND

• Ungerstedt JS, Blomback M, Soderstrom T. Nicotinamide is a potent inhibitor of proinflammatory cytokines. Clin Exp Immunol. 2003 Jan;131(1):48-52. doi: 10.1046/j.1365-2249.2003.02031.x.

  PMID: 12519385 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Lamia El wakeel, Professor

  Professor and head of department of Clinical Pharmacy at Faculty of Pharmacy Ain Shams University

  STUDY DIRECTOR

• May Ahmed, Asst. professor

  Assistant professor of Clinical Pharmacy, Ain Shams University-Faculty of Pharmacy

  STUDY DIRECTOR

Central Study Contacts

Sara A. Raslan, Bachelor

CONTACT

+20 1020145174; Sarah.raslan@pharma.asu.edu.eg

Dalia Abdelmohsen, Professor

CONTACT

+20 100 1580007; d_mohsen@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pharmacist at Ain Shams University Hospitals

Model Details: A prospective randomized controlled interventional parallel open label study.

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: December 2, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)