Impact of Vitamin D in Rheumatoid Arthritis

Phase 4

Completed

• Conditions: Rheumatic Arthritis
• Interventions: Drug: Vitamin D

• Registration Number: NCT06716476
• Lead Sponsor: University of Pristina

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2023-03-31
• Study Completion: 2024-01-31
• Status Verified: 2024-11
• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-28
• Last Update Submitted: 2024-11-28
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with Vitamin D	Vitamin D	RA Patients with Vitamin D

Primary Outcome Measures

Name	Time	Method
Level of 25(OH)D in serum	6 months	25(OH)D level in ng/mL (0-30 ng/mL)
Serum level of inflammatory mediators of RA (IL6, IL17, CRP, TNF-alpha)	6 months	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

Secondary Outcome Measures

Name	Time	Method
VAS: Visual analogue scale	6 months	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')
DAS28: Disease Activity Score-28	6 months	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.

Trial Locations

Locations (1)

Faculty of Medicine University of Prishtina; Prishtina, Kosovo