NCT06716476CompletedPhase 4
Impact of Vitamin D in Rheumatoid Arthritis
Impact of Vitamin D in Modulating Disease Activity and Inflammatory Mediators in Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 4 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 22 Nov 2024
- Start date
- 1 Mar 2022
- Primary completion date
- 31 Mar 2023
- Lead sponsor
- University of Pristina
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06716476
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 100
- From 1 Mar 2022 to the primary completion date, 31 Mar 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Last 3 months treatment with Ca \> 1g/per day;
- Last 3 months treatment with vitamin D supplements
Other illness
- Other inflammatory diseases;
- Thyroid and parathyroid diseases;
- Liver and kidney disease;
Who the study is looking for
- Rheumatoid Arthritis Caucasian patients,
- Kosovar ethnicity,
- Both genders,
- 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
Age in the registry: 30 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine University of Prishtina Coordinator of this site? Confirm its status | Pristina | Kosovo | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.