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
About this trial
This is an interventional treatment trial for the Immunomodulatory Effect
Eligibility Criteria
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
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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