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NCT04472481

Vitamin D Effect in Rheumatoid Arthritis.

Completed Phase 4 Last updated 15 July 2020
What this trial tests

Phase 4 trial testing Ergocalciferol 1.25 mg tablet in Active Rheumatoid Arthritis in 20 participants. Completed in 22 March 2020.

Timeline
6 September 2019
Primary endpoint
22 December 2019
22 March 2020

Quick facts

Lead sponsorTanta University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date6 September 2019
Primary completion22 December 2019
Estimated completion22 March 2020
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Tanta University

Who can join

Adults 33 to 60, any sex, with Active Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Enhancing Regulatory T Cells to Treat Inflammatory and Autoimmune Diseases.
    Fiyouzi T, Pelaez-Prestel HF, Reyes-Manzanas R, Lafuente EM, et al · · 2023 · cited 27× · PMID 37175505 · DOI 10.3390/ijms24097797
  2. Vitamin D: does it help Tregs in active rheumatoid arthritis patients.
    El-Banna HS, Gado SE. · · 2020 · cited 14× · PMID 32783547 · DOI 10.1080/1744666x.2020.1805317
  3. Regulatory T lymphocytes as a treatment method for rheumatoid arthritis - Superiority of allogeneic to autologous cells.
    Chmiel J, Stasiak M, Skrzypkowska M, Samson L, et al · · 2024 · cited 2× · PMID 39319132 · DOI 10.1016/j.heliyon.2024.e36512
  4. The Role of Vitamin D in Autoimmune Diseases.
    Vincenzi F, Smirne C, Tonello S, Sainaghi PP. · · 2026 · PMID 41516427 · DOI 10.3390/ijms27010555

Verify or expand the search:

Other recruiting trials for Active Rheumatoid Arthritis

Currently open trials in the same condition.

Other Tanta University trials

Trials by the same sponsor.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing