Rheumatic ArthritisPhase 4NCT06716476
Impact of Vitamin D in Rheumatoid Arthritis
A Phase 4 study testing Vitamin D in people with Rheumatic Arthritis, run by University of Pristina at 1 site in Kosovo.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Rheumatic Arthritis
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteKosovo
- Study dates
- 1 Mar 2022to 31 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read more
- 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.
Read the 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.
- Conditions
- Rheumatic Arthritis
- Being tested
- Vitamin D
- Keywords
- Modulating Disease Activity and Inflammatory mediators
- Medical subject headings
- Rheumatic Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Supplemental with Vitamin D 4000 IU
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Vitamin D | Active comparator | RA Patients with Vitamin D Receives: Drug: Vitamin D |
| No treatment with Vitamin D | No intervention | RA Patients without Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of 25(OH)D in serum
25(OH)D level in ng/mL (0-30 ng/mL)
Measured: 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
Measured: 6 months
Secondary outcomes (2)
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')
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Mar 2022
- Primary completion31 Mar 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rheumatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pristina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaip Krasniqi, University of Pristina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716476
- Sponsor's protocol ID
- UPristina
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Higgins MJ, Mackie SL, Thalayasingam N, Bingham SJ, Hamilton J, Kelly CA. The effect of vitamin D levels on the assessment of disease activity in rheumatoid arthritis. Clin Rheumatol. 2013 Jun;32(6):863-7. doi: 10.1007/s10067-013-2174-x. Epub 2013 Jan 23.
PubMed 23340834Chandrashekara S, Patted A. Role of vitamin D supplementation in improving disease activity in rheumatoid arthritis: An exploratory study. Int J Rheum Dis. 2017 Jul;20(7):825-831. doi: 10.1111/1756-185X.12770. Epub 2015 Oct 20.
PubMed 26481198Fassio A, Gatti D, Rossini M, Bertelle D, Bixio R, Viapiana O, Milleri S, Benini C, Pistillo F, Zanetti G, Adami G. Effects on Serum Inflammatory Cytokines of Cholecalciferol Supplementation in Healthy Subjects with Vitamin D Deficiency. Nutrients. 2022 Nov 14;14(22):4823. doi: 10.3390/nu14224823.
PubMed 36432510Adams JS, Hewison M. Unexpected actions of vitamin D: new perspectives on the regulation of innate and adaptive immunity. Nat Clin Pract Endocrinol Metab. 2008 Feb;4(2):80-90. doi: 10.1038/ncpendmet0716.
PubMed 18212810Al-Saoodi H, Kolahdooz F, Andersen JR, Jalili M. Effect of vitamin D on inflammatory and clinical outcomes in patients with rheumatoid arthritis: a systematic review and dose-response meta-analysis of randomized controlled trials. Nutr Rev. 2024 Apr 12;82(5):600-611. doi: 10.1093/nutrit/nuad083.
PubMed 37437898Steiner G, Van Hoovels L, Csige D, Gatto M, Iagnocco A, Szekanecz Z. Should ACR/EULAR criteria be revised changing the RF and ACPA scores? Autoimmun Rev. 2024 Jan;23(1):103421. doi: 10.1016/j.autrev.2023.103421. Epub 2023 Aug 24.
PubMed 37633353Rexhepi M, Krasniqi B, Hoti K, Daci A, Rexhepi-Kelmendi B, Krasniqi S. Impact of vitamin D supplementation on disease activity and pain management in rheumatoid arthritis: a randomized double-blinded controlled study. BMC Rheumatol. 2025 Jul 11;9(1):87. doi: 10.1186/s41927-025-00543-6.
PubMed 40646666
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D in Modulating Disease Activity and Inflammatory Mediators in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06716476
- Acronym / sponsor ID
- UPristina
- Conditions
- Rheumatic Arthritis
- Keywords
- Modulating Disease Activity and Inflammatory mediators
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PristinaUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Vitamin D | Active comparator | Drug: Vitamin DRA Patients with Vitamin D |
| No treatment with Vitamin D | No intervention | –RA Patients without Vitamin D |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- RA disease duration 1-14 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DSupplemental with Vitamin D 4000 IU | Drug | Treatment with Vitamin D |
Primary outcome
Level of 25(OH)D in serum
Time frame: 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)
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
2 secondary outcomes
VAS: Visual analogue scale
Time frame: 6 months
DAS28: Disease Activity Score-28
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Background: PubMed 23340834Higgins MJ, Mackie SL, Thalayasingam N, Bingham SJ, Hamilton J, Kelly CA. The effect of vitamin D levels on the assessment of disease activity in rheumatoid arthritis. Clin Rheumatol. 2013 Jun;32(6):863-7. doi: 10.1007/s10067-013-2174-x. Epub 2013 Jan 23.
- Background: PubMed 26481198Chandrashekara S, Patted A. Role of vitamin D supplementation in improving disease activity in rheumatoid arthritis: An exploratory study. Int J Rheum Dis. 2017 Jul;20(7):825-831. doi: 10.1111/1756-185X.12770. Epub 2015 Oct 20.
- Background: PubMed 36432510Fassio A, Gatti D, Rossini M, Bertelle D, Bixio R, Viapiana O, Milleri S, Benini C, Pistillo F, Zanetti G, Adami G. Effects on Serum Inflammatory Cytokines of Cholecalciferol Supplementation in Healthy Subjects with Vitamin D Deficiency. Nutrients. 2022 Nov 14;14(22):4823. doi: 10.3390/nu14224823.
- Background: PubMed 18212810Adams JS, Hewison M. Unexpected actions of vitamin D: new perspectives on the regulation of innate and adaptive immunity. Nat Clin Pract Endocrinol Metab. 2008 Feb;4(2):80-90. doi: 10.1038/ncpendmet0716.
- Background: PubMed 37437898Al-Saoodi H, Kolahdooz F, Andersen JR, Jalili M. Effect of vitamin D on inflammatory and clinical outcomes in patients with rheumatoid arthritis: a systematic review and dose-response meta-analysis of randomized controlled trials. Nutr Rev. 2024 Apr 12;82(5):600-611. doi: 10.1093/nutrit/nuad083.
- Background: PubMed 37633353Steiner G, Van Hoovels L, Csige D, Gatto M, Iagnocco A, Szekanecz Z. Should ACR/EULAR criteria be revised changing the RF and ACPA scores? Autoimmun Rev. 2024 Jan;23(1):103421. doi: 10.1016/j.autrev.2023.103421. Epub 2023 Aug 24.
- Derived from this study: PubMed 40646666Rexhepi M, Krasniqi B, Hoti K, Daci A, Rexhepi-Kelmendi B, Krasniqi S. Impact of vitamin D supplementation on disease activity and pain management in rheumatoid arthritis: a randomized double-blinded controlled study. BMC Rheumatol. 2025 Jul 11;9(1):87. doi: 10.1186/s41927-025-00543-6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Rheumatic Arthritis, run by University of Pristina at 1 site in Kosovo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kosovo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of 25(OH)D in serum (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06716476, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.