the Immunomodulatory Effect Clinical Trial
Official title:
Vitamin D as a Key Player in Rheumatoid Arthritis Immune Response
| Verified date | June 2021 |
| Source | Assiut University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | June 1, 2021 |
| Est. primary completion date | January 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 70 Years |
| Eligibility | Inclusion Criteria: - RA patients Exclusion Criteria: - Patients with inflammatory bowel disease patients with any other autoimmune diseases |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Manal Hassanien | Assiut | Assuit |
| Lead Sponsor | Collaborator |
|---|---|
| Assiut University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | disease activity score 28 | disease activity score | 3 months |