Impact of Vitamin D in Rheumatoid Arthritis

November 28, 2024 updated by: Shaip Krasniqi, University of Pristina

Impact of Vitamin D in Modulating Disease Activity and Inflammatory Mediators in Rheumatoid Arthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kosovo
      • Prishtina, Kosovo, 10000
        • Faculty of Medicine University of Prishtina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment with Vitamin D
RA Patients with Vitamin D
Drug: Vitamin D
Supplemental with Vitamin D 4000 IU
No Intervention: No treatment with Vitamin D
RA Patients without Vitamin D

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS: Visual analogue scale
Time Frame: 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')
6 months
DAS28: Disease Activity Score-28
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pristina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

November 28, 2024

First Posted (Estimated)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPristina

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe