NCT04472481

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

July 7, 2020

Last Update Submit

July 14, 2020

Conditions

Active Rheumatoid Arthritis

Keywords

Regulatory T cellFoxp3+vitamin D supplementationRheumatoid arthritisDMARD

Outcome Measures

Primary Outcomes (1)

  • 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.

    base line and after 3 months

Study Arms (1)

group II

OTHER

50000 IU of Vitamin D2 (Ergocalciferol 1.25 mg tablet) weekly for 3 months

Drug: Ergocalciferol 1.25 mg tablet

Interventions

Ergocalciferol 1.25 mg tabletDRUG

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

group II

Eligibility Criteria

Age33 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Souzan Ezzat Gado

Tanta, EL-gharbia, 31111, Egypt

Location

Related Publications (3)

  • Wang Z, Chang C, Lu Q. Epigenetics of CD4+ T cells in autoimmune diseases. Curr Opin Rheumatol. 2017 Jul;29(4):361-368. doi: 10.1097/BOR.0000000000000393.

    PMID: 28362657BACKGROUND

  • Lan Q, Fan H, Quesniaux V, Ryffel B, Liu Z, Zheng SG. Induced Foxp3(+) regulatory T cells: a potential new weapon to treat autoimmune and inflammatory diseases? J Mol Cell Biol. 2012 Feb;4(1):22-8. doi: 10.1093/jmcb/mjr039. Epub 2011 Nov 22.

    PMID: 22107826BACKGROUND

  • El-Banna HS, Gado SE. Vitamin D: does it help Tregs in active rheumatoid arthritis patients. Expert Rev Clin Immunol. 2020 Aug;16(8):847-853. doi: 10.1080/1744666X.2020.1805317. Epub 2020 Aug 25.

    PMID: 32783547DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ErgocalciferolsTablets

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsDosage FormsPharmaceutical Preparations

Study Officials

  • Souzan E Gado, MD

    Lecturer

    PRINCIPAL INVESTIGATOR

  • Hanaa S EL-banna, MD

    Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Rheumatology,physical medicine &Rehabilitation.

Study Record Dates

First Submitted

July 7, 2020

First Posted

July 15, 2020

Study Start

September 6, 2019

Primary Completion

December 22, 2019

Study Completion

March 22, 2020

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)