Impact of vitamin D supplementation on disease activity and pain management in rheumatoid arthritis: a randomized double-blinded controlled study

Abstract Background Rheumatoid arthritis (RA) is a progressive autoimmune disease. During complex therapy, vitamin D supplementation could have an immunomodulatory effect and improve disease activity. Aim The aim of this study was to investigate the effects of vitamin D supplementation on laboratory...

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Main Authors: Mjellma Rexhepi, Blana Krasniqi, Kreshnik Hoti, Armond Daci, Blerta Rexhepi-Kelmendi, Shaip Krasniqi
Format: Article
Language:English
Published: BMC 2025-07-01
Series:BMC Rheumatology
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Online Access:https://doi.org/10.1186/s41927-025-00543-6
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author Mjellma Rexhepi
Blana Krasniqi
Kreshnik Hoti
Armond Daci
Blerta Rexhepi-Kelmendi
Shaip Krasniqi
author_facet Mjellma Rexhepi
Blana Krasniqi
Kreshnik Hoti
Armond Daci
Blerta Rexhepi-Kelmendi
Shaip Krasniqi
author_sort Mjellma Rexhepi
collection DOAJ
description Abstract Background Rheumatoid arthritis (RA) is a progressive autoimmune disease. During complex therapy, vitamin D supplementation could have an immunomodulatory effect and improve disease activity. Aim The aim of this study was to investigate the effects of vitamin D supplementation on laboratory parameters and the disease course among patients with RA. Methods This prospective, randomized, parallel-group, double-blind study with a follow-up period of 6 months aimed to investigate the effects of 4000 IU/day vitamin D on visual analogue scale (VAS) and disease activity score-28 (DAS-28) scores among RA patients treated at the Rheumatology Clinic of the University Clinical Centre of Kosova. The study included 100 RA patients (82 women and 18 men) who were divided into two groups: patients with vitamin D supplementation and patients without vitamin D supplementation. Results Our results revealed no significant differences in baseline clinical or laboratory parameters between the study groups. At the beginning of the study, to ensure homogeneity between the study groups, we compared inflammatory mediators between groups. We found no significant differences in the IL6 (H statistic of 1.79 for p.180), IL17 (H statistic of 0.015 for p.902), TNF (H statistic of 1.15 for p.284), ESR (H statistic of 0.085 for p.771) or CRP (H statistic of 1.45 for p.229) levels between the two groups. After six months of supplementation therapy, the vitamin D group showed significant differences in pain reduction (VAS score, U’=2245.5; P < 0.0001) and disease activity (DAS28 score, U’=2285.5; P < 0.0001). Conclusions Supplementation with 4000 IU/day of vitamin D can potentially improve disease activity and pain management among RA patients after six months. However, further research is needed with a focus on longer patient follow-up periods to determine the long-term benefits of vitamin D in RA patients. Trial registration ID NCT06716476, Date of Registration 04.12.2024.
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spelling doaj-art-ff593a7baf324f6a8c1afd5e031f2c022025-08-20T03:46:16ZengBMCBMC Rheumatology2520-10262025-07-019111210.1186/s41927-025-00543-6Impact of vitamin D supplementation on disease activity and pain management in rheumatoid arthritis: a randomized double-blinded controlled studyMjellma Rexhepi0Blana Krasniqi1Kreshnik Hoti2Armond Daci3Blerta Rexhepi-Kelmendi4Shaip Krasniqi5Rheumatology Clinic-University Clinical Centre of KosovaMedical University of Tirana-Faculty of MedicineDepartment of Pharmacy, Faculty of Medicine, University of PrishtinaDepartment of Pharmacy, Faculty of Medicine, University of PrishtinaRheumatology Clinic-University Clinical Centre of KosovaInstitute of Clinical Pharmacology, Faculty of Medicine, University of PrishtinaAbstract Background Rheumatoid arthritis (RA) is a progressive autoimmune disease. During complex therapy, vitamin D supplementation could have an immunomodulatory effect and improve disease activity. Aim The aim of this study was to investigate the effects of vitamin D supplementation on laboratory parameters and the disease course among patients with RA. Methods This prospective, randomized, parallel-group, double-blind study with a follow-up period of 6 months aimed to investigate the effects of 4000 IU/day vitamin D on visual analogue scale (VAS) and disease activity score-28 (DAS-28) scores among RA patients treated at the Rheumatology Clinic of the University Clinical Centre of Kosova. The study included 100 RA patients (82 women and 18 men) who were divided into two groups: patients with vitamin D supplementation and patients without vitamin D supplementation. Results Our results revealed no significant differences in baseline clinical or laboratory parameters between the study groups. At the beginning of the study, to ensure homogeneity between the study groups, we compared inflammatory mediators between groups. We found no significant differences in the IL6 (H statistic of 1.79 for p.180), IL17 (H statistic of 0.015 for p.902), TNF (H statistic of 1.15 for p.284), ESR (H statistic of 0.085 for p.771) or CRP (H statistic of 1.45 for p.229) levels between the two groups. After six months of supplementation therapy, the vitamin D group showed significant differences in pain reduction (VAS score, U’=2245.5; P < 0.0001) and disease activity (DAS28 score, U’=2285.5; P < 0.0001). Conclusions Supplementation with 4000 IU/day of vitamin D can potentially improve disease activity and pain management among RA patients after six months. However, further research is needed with a focus on longer patient follow-up periods to determine the long-term benefits of vitamin D in RA patients. Trial registration ID NCT06716476, Date of Registration 04.12.2024.https://doi.org/10.1186/s41927-025-00543-6Rheumatoid arthritisVitamin D supplementationVASDAS28
spellingShingle Mjellma Rexhepi
Blana Krasniqi
Kreshnik Hoti
Armond Daci
Blerta Rexhepi-Kelmendi
Shaip Krasniqi
Impact of vitamin D supplementation on disease activity and pain management in rheumatoid arthritis: a randomized double-blinded controlled study
BMC Rheumatology
Rheumatoid arthritis
Vitamin D supplementation
VAS
DAS28
title Impact of vitamin D supplementation on disease activity and pain management in rheumatoid arthritis: a randomized double-blinded controlled study
title_full Impact of vitamin D supplementation on disease activity and pain management in rheumatoid arthritis: a randomized double-blinded controlled study
title_fullStr Impact of vitamin D supplementation on disease activity and pain management in rheumatoid arthritis: a randomized double-blinded controlled study
title_full_unstemmed Impact of vitamin D supplementation on disease activity and pain management in rheumatoid arthritis: a randomized double-blinded controlled study
title_short Impact of vitamin D supplementation on disease activity and pain management in rheumatoid arthritis: a randomized double-blinded controlled study
title_sort impact of vitamin d supplementation on disease activity and pain management in rheumatoid arthritis a randomized double blinded controlled study
topic Rheumatoid arthritis
Vitamin D supplementation
VAS
DAS28
url https://doi.org/10.1186/s41927-025-00543-6
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