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OpenTrials
Completed

NCT Number: NCT04472481

Vitamin D Effect in Rheumatoid Arthritis.

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.

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Key information

Age range

33 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Souzan Ezzat Gado

Tanta, EL-gharbia, 31111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • disease duration less than 3 years from the time of diagnosis, age more than 18 years, a diagnosis of RA according to the 2010 ACR/ EULAR Classification criteria for RA diagnosis , active disease according to DAS-28, for those receiving nonsteroidal anti-inflammatory drugs and corticosteroids, the dosage had to be stable for at least 2 weeks before screening.

Exclusion criteria

  • Patients with allergic, and infectious diseases, patients receiving steroids for the first time within 2 weeks before the study, patients with hypercalcemia, hypercalciuria, nephrolithiasis, or neoplastic diseases were excluded from the study. We also excluded patients on any biologic therapy and patients with prior use of leflunomide, hydroxychloroquine, or sulphasalazine for more than 2 months.

Treatment and study plan

Ergocalciferol 1.25 mg tablet

Drug

weekly 50000 IU of Vitamin D2 (Ergocalciferol 1.25 mg tablet) given orally group II

Primary outcomes

  1. change from base line Measurement of regulatory T cells (CD4+CD25+FoxP3+) at 3 months

    Time frame: base line and after 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Vitamin D: Does It Help Tregs in Active Rheumatoid Arthritis Patients.

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 15, 2020
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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