Impact of Vitamin D in Rheumatoid Arthritis

NCT06716476 | Completed Phase 4

• 1 other identifier: UPristina
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatic Arthritis

Keywords

Modulating Disease Activity and Inflammatory mediators

Outcome Measures

Primary Outcomes (2)

• Level of 25(OH)D in serum

  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)

  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 Outcomes (2)

• VAS: Visual analogue scale

  6 months

• DAS28: Disease Activity Score-28

  6 months

Study Arms (2)

Treatment with Vitamin D

ACTIVE COMPARATOR

RA Patients with Vitamin D

Drug: Vitamin D

No treatment with Vitamin D

NO INTERVENTION

RA Patients without Vitamin D

Interventions

Vitamin D DRUG

Supplemental with Vitamin D 4000 IU

Treatment with Vitamin D

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pristina: lead

Study Sites (1)

Faculty of Medicine University of Prishtina

Pristina, 10000, Kosovo

Location

Related Publications (7)

• 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.

  PMID: 23340834 BACKGROUND

• Chandrashekara 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.

  PMID: 26481198 BACKGROUND

• Fassio 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.

  PMID: 36432510 BACKGROUND

• Adams 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.

  PMID: 18212810 BACKGROUND

• Al-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.

  PMID: 37437898 BACKGROUND

• Steiner 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.

  PMID: 37633353 BACKGROUND

• Rexhepi 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.

  PMID: 40646666 DERIVED

MeSH Terms

Conditions

Rheumatic Fever

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Med. Shaip Krasniqi - Clinical Pharmacologist

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 4, 2024
• Study Start: March 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: January 31, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

KO (1)