A Phase 4 interventional study of Ergocalciferol 1.25 mg tablet in Active Rheumatoid Arthritis, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 33 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-15.
Sponsored by Tanta University · Phase 4, Interventional, and Treatment
Regulatory T (Tregs) cells play an important role in the maintenance of immunological tolerance. It decrease in the peripheral blood of rheumatoid arthritis patients. Vitamin D has an immunomodulatory and anti-inflammatory effect in rheumatoid arthritis.
Vitamin D supplementation significantly enhances Tregs percentage in the peripheral blood of RA patients. So supplementation of Vit D improves rheumatoid arthritis disease activity.
Background: Regulatory T cells (Tregs) play an important role in the maintenance of immunological tolerance, so Tregs deficiency or decrease suppressor functions may be associated with development of autoimmune diseases.
Vitamin D is essential for normal bone mineralization and growth, prevention of osteopenia, osteoporosis, and nonspecific painful musculoskeletal conditions . Vitamin D is thought to have an immunomodulatory and anti-inflammatory actions, as its receptors are widely expressed in peripheral mononuclear blood cells, also its deficiency associated with several autoimmune disorders, including rheumatoid arthritis
Methods: 40 patients with active RA were randomly assigned into two groups. Group I received MTX plus hydroxychloroquine, group II received MTX and hydroxychloroquine plus vitamin D supplementation for 3 months, in addition to 30 healthy volunteers as control group. Peripheral blood Tregs were measured by Flow Cytometry.
Statistical Analysis. The collected data analyzed by SPSS software (version 16). The range, mean and standard deviation were calculated for quantitative variables. Categorical variables were expressed as number and percentages; Chi square was used as a test of their significance. Skewness, kurtosis; Shapiro-Wilk, and The Kolmogorov-Smirnov tests were used to test the normality for the data. The difference between two means was analyzed using the students (t) test (paired and unpaired samples- T tests). Significance was considered at p\<0.05.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 20 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
50000 IU of Vitamin D2 (Ergocalciferol 1.25 mg tablet) weekly for 3 months
Drug: Ergocalciferol 1.25 mg tablet
weekly 50000 IU of Vitamin D2 (Ergocalciferol 1.25 mg tablet) given orally group II
change from base line Measurement of regulatory T cells (CD4+CD25+FoxP3+) at 3 months
4 ml of heparinized blood from the subjects' peripheral blood was collected. Human peripheral blood natural regulatory T cells (Tregs) were surface stained with Mouse Anti-Human CD4 FITC (Fluorescein) conjugated Monoclonal Antibody and Mouse Anti-Human IL-2 Rα/CD25 APC (allophycocyanin) conjugated Monoclonal Antibody, followed by intracellular staining using Rabbit Anti-Human/ Mouse FoxP3 PE (phycoerythrin) conjugated Antigen Affinity-purified Monoclonal Antibody, cells were fixed and permeabilized with FoxP3 Fixation \& Permeabilization Buffer Kit. Cells were gated on lymphocytes.
Time frame: base line and after 3 months
Plan to share: No
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Tanta University