A Phase 4 interventional study of Vitamin D in Rheumatic Arthritis, sponsored by University of Pristina. Completed at 1 site in Kosovo. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by University of Pristina · Phase 4, Interventional, and Treatment
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
Participants in active group will:
Rheumatoid arthritis (RA) is an idiopathic autoimmune disease with a chronic course of exacerbations and remissions with more frequent incidence in females, characterized by inflammation, pain, and progressive damage to the joints. The main focus of our study is to evaluate the impact of Vitamin D besides other standard therapies in the group of people with RA, assessing the inflammatory mediators and clinical course of the disease in the baseline and after six months.
This is a prospective, randomized, controlled Trial (RCT) with a Parallel-Group Design, ensuring that changes in inflammation markers and disease activity over time will be measured simultaneously and independently.
Before enrolment, the research dossier, including the patient's informed consent, was submitted to the Medical Chamber of Kosovo Ethics Committee for approval. This professional body approved this study, and the approval letter was issued to the research team. Patients were included in the study only after signing the consent form and after being fully informed about the research.
The participants will be patients which fulfils the diagnostic criteria for Rheumatoid Arthritis (RA) of American college of Rheumatology (ACR)/European league against rheumatism (EULAR) - ACR/EULAR 2010. The cohort of participants will be elected after evaluation of inclusion and exclusion criteria of participants:
The trial participants will be enrolled from a cohort of people with RA disease treated at the University Clinical Centre of Kosovo-Rheumatology Clinic in Prishtina. The data will be collected for one year.
In both group of participants at the baseline will be measured the level of 25-hydroxyvitamin D [25(OH)D] and inflammatory mediators of RA: Interleukin 6 (IL6) , Interleukin 17 (IL17), CRP, TNF-alpha). Moreover, in both groups participants will be determined the activity of disease measuring the visual analogue scale (VAS) and Disease Activity Score-28 (DAS-28 score). The intervention group of participants will receive the Vitamin D supplementation for 6 months while other group of participants will not receive the Vitamin D and after 6 months will be evaluated level of [25(OH)D] and inflammatory mediators of RA: Interleukin 6 (IL6) , Interleukin 17 (IL17), CRP, TNF-alpha) and VAS and Das28 and compare with baseline data.
55 studies on the registry are indexed under Rheumatic Fever; 21 are open to participants now.
This study's enrollment of 100 is above the median of 70 across 28 interventional studies indexed under Rheumatic Fever.
Browse Rheumatic Fever studies →University of Pristina is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria
Inclusion criteria:
Patients with proven rheumatoid arthritis diagnosis ACR/EULAR 2010 grouped into four classifications with point scores for each:
Exclusion criteria:
RA Patients with Vitamin D
Drug: Vitamin D
RA Patients without Vitamin D
Supplemental with Vitamin D 4000 IU
Level of 25(OH)D in serum
25(OH)D level in ng/mL (0-30 ng/mL)
Time frame: 6 months
Serum level of inflammatory mediators of RA (IL6, IL17, CRP, TNF-alpha)
IL-6 pg/mL \< 12.0 IL-17 (pg/mL) \<1.4 pg/mL TNF Alpha (pg/mL) 4.6 - 12.4 pg/mL CRP (mg/l) \<6mg/L
Time frame: 6 months
VAS: Visual analogue scale
The Visual Analogue Scale (VAS) measures pain intensity. The measurement unit 0 - 10 unit. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Time frame: 6 months
DAS28: Disease Activity Score-28
The DAS28 is a measure of disease activity in RA; an online tool collates a clinical assessment of 28 specified joints, serum inflammatory markers, and a visual analog scale (0-10) of the patient's global function. A score greater than 5.1 indicates active disease and less than 3.2 indicates well-controlled disease.
Time frame: 6 months
Plan to share: Undecided
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Vitamin D
University of Pristina