Clinical trial NCT04472481: Vitamin D Effect in Rheumatoid Arthritis.
Official title: Vitamin D: Does It Help Tregs in Active Rheumatoid Arthritis Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Active Rheumatoid Arthritis
Keywords: Regulatory T cell
Foxp3+
vitamin D supplementation
Rheumatoid arthritis
DMARD
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 20
Sex: ALL
Minimum age (years): 33
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: change from base line Measurement of regulatory T cells (CD4+CD25+FoxP3+) at 3 months
timeFrame: base line and after 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Souzan Ezzat Gado
state: EL-gharbia
Study officials:
affiliation: Lecturer
name: Souzan E Gado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer
name: Hanaa S EL-banna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.