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Vitamin D as a Key Player in Rheumatoid Arthritis

Primary Purpose

the Immunomodulatory Effect

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D
Steroid Drug
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for the Immunomodulatory Effect

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • RA patients

Exclusion Criteria:

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

Sites / Locations

  • Manal Hassanien

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vit D

control

Arm Description

Outcomes

Primary Outcome Measures

disease activity score 28
disease activity score

Secondary Outcome Measures

Full Information

First Posted
April 9, 2020
Last Updated
June 20, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04344405
Brief Title
Vitamin D as a Key Player in Rheumatoid Arthritis
Official Title
Vitamin D as a Key Player in Rheumatoid Arthritis Immune Response
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
the Immunomodulatory Effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vit D
Arm Type
Experimental
Arm Title
control
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
vitamin D supplementation
Intervention Type
Drug
Intervention Name(s)
Steroid Drug
Intervention Description
control
Primary Outcome Measure Information:
Title
disease activity score 28
Description
disease activity score
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: RA patients Exclusion Criteria: Patients with inflammatory bowel disease patients with any other autoimmune diseases
Facility Information:
Facility Name
Manal Hassanien
City
Assiut
State/Province
Assuit
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Vitamin D as a Key Player in Rheumatoid Arthritis

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