Vitamin D as a Key Player in Rheumatoid Arthritis
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 9, 2020
CompletedFirst Posted
Study publicly available on registry
April 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJune 24, 2021
June 1, 2021
7 months
April 9, 2020
June 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
disease activity score 28
disease activity score
3 months
Study Arms (2)
Vit D
EXPERIMENTALcontrol
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- RA patients
You may not qualify if:
- Patients with inflammatory bowel disease patients with any other autoimmune diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Manal Hassanien
Asyut, Assuit, 71111, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
April 9, 2020
First Posted
April 14, 2020
Study Start
June 1, 2019
Primary Completion
January 1, 2020
Study Completion
June 1, 2021
Last Updated
June 24, 2021
Record last verified: 2021-06