Impact of Vitamin D in Rheumatoid Arthritis

About this trial

Last updated a year ago

Study ID

UPristina

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

Accepting

30 to 65 Years

All Sexes

Trial Timing

Ended 2 years ago

What is this trial about?

The goal of this prospective, randomized, parallel-group design, double-blind, and 6-month follow-up is to evaluate the impact of 4000 IU/day vitamin D on 25-hydroxyvitamin D [25(OH)D] levels and inflammatory mediators in people with Rheumatoid Arthritis (RA). The main questions it aims to answer are * The level of 25(OH)D and inflammatory mediators of levels of RA differs at baseline and after 6 months of Vitamin D 4000 UI * The disease activity of AR measured by visual analogue scale (VAS) and Disease Activity Score-28 (DAS-28 score) will change in baseline and after 6 months of Vitamin D 4000 UI Researchers will compare the group of participants with Vitamin D supplementation and group of participants without D Vitamin supplementation Participants in active group will: * Take Vitamin D every day for 6 months * Visit the clinic in the first months and after 6 months for medical visits and tests.

What are the Participation Requirements?

Inclusion criteria * Rheumatoid Arthritis Caucasian patients, * Kosovar ethnicity, * Both genders, Inclusion criteria: * Patients with proven rheumatoid arthritis diagnosis ACR/EULAR 2010 grouped into four classifications with point scores for each: * joint symptoms; * serology (including RF and/or ACPA); * symptom duration, whether <6 weeks or >6 weeks; and * acute-phase reactants (CRP and/or ESR). Point scores ≥6/10 was criteria for AR diagnosis; * RA disease duration 1-14 years Exclusion criteria: * Other inflammatory diseases; * Thyroid and parathyroid diseases; * Liver and kidney disease; * Last 3 months treatment with Ca > 1g/per day; * Last 3 months treatment with vitamin D supplements