Impact of Vitamin D in Rheumatoid Arthritis

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.

Timeline

Start

2022-03-01

Primary completion

2023-03-31

Completion

2024-01-31

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications