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OpenTrials
Completed

NCT Number: NCT04344405

Vitamin D as a Key Player in Rheumatoid Arthritis

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.

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Key information

Conditions

the Immunomodulatory Effect

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Manal Hassanien

Asyut, Assuit, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • RA patients

Exclusion criteria

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

Treatment and study plan

Vitamin D

Drug

vitamin D supplementation

Steroid Drug

Drug

control

Primary outcomes

  1. disease activity score 28

    Time frame: 3 months

    disease activity score

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Vitamin D as a Key Player in Rheumatoid Arthritis Immune Response

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 14, 2020
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.