Vitamin D as a Key Player in Rheumatoid Arthritis

Phase 3

Completed

• Conditions: the Immunomodulatory Effect
• Interventions: Drug: Vitamin D; Drug: Steroid Drug

• Registration Number: NCT04344405
• Lead Sponsor: Assiut University

Brief Summary

Rheumatoid arthritis (RA) is a systemic, chronic and inflammatory disease of joints linked to autoimmunity. Vitamin D was found to modulate cell growth, function of immune cells and anti-inflammatory action. The aim of this study was to investigate serum vitamin D level and some cytokines and to identify the correlation between vitamin D and these cytokines in RA.

Methods: Totally 60 RA patients without vitamin D supplement were involved in this study. The serum level of vitamin D, interleukin-6 (IL-6), IL-10, IL-35, tumor necrosis factor α (TNF-α) and C-reactive protein (CRP) were measure in all patients by enzyme-linked immunosorbent assay (ELISA) then they will divided into 2 groups, group I receive vit. D supplementation and group II will receive placebo and follow up for 3 months.

Detailed Description

Rheumatoid arthritis (RA) is a systemic, chronic and inflammatory disease of joints linked to autoimmunity. Vitamin D was found to modulate cell growth, function of immune cells and anti-inflammatory action. The aim of this study was to investigate serum vitamin D level and some cytokines and to identify the correlation between vitamin D and these cytokines in RA.

Methods: Totally 60 RA patients without vitamin D supplement were involved in this study. The serum level of vitamin D, interleukin-6 (IL-6), IL-10, IL-35, tumor necrosis factor α (TNF-α) and C-reactive protein (CRP) were measure in all patients by enzyme-linked immunosorbent assay (ELISA) then they will divided into 2 groups, group I receive vit. D supplementation and group II will receive placebo and follow up for 3 months.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2020-01-01
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-14
• Status Verified: 2021-06
• Study Completion: 2021-06-01
• Last Update Submitted: 2021-06-20
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• RA patients

Exclusion Criteria

• Patients with inflammatory bowel disease patients with any other autoimmune diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vit D	Vitamin D	-
control	Steroid Drug	-

Primary Outcome Measures

Name	Time	Method
disease activity score 28	3 months	disease activity score

Trial Locations

Locations (1)

Manal Hassanien; 🇪🇬 Assiut, Assuit, Egypt