Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients: A Randomized Clinical Trial Study
Keywords:
cholecalciferol, disease activity, quality of life, systemic lupus erythematosusAbstract
Background: Increase in the prevalence and survival rates has led to the assessment of disease activity and quality of life of SLE patients as targets in treatment. Cholecalciferol was considered as having a role in reducing disease activity and improving quality of life. Methods: A double blind, randomized, controlled trial was conducted on female outpatients aged 18-60 years with SLE, consecutively recruited from September to December 2021 at Cipto Mangunkusumo Hospital. Sixty subjects who met the research criteria were randomized and equally assigned into the cholecalciferol and placebo groups. The study outcomes were measured at baseline and after 12 weeks of intervention. Results: Out of 60 subjects, 27 subjects in cholecalciferol group and 25 subjects in placebo group completed the intervention. There was a significant improvement on the level of vitamin D (ng/ml) after intervention in the cholecalciferol group, from an average of 15,69 ng/ml (8.1-28.2) to 49,90 ng/ml (26-72.1), and for the placebo group from 15,0 ng/ml (8.1-25,0) to 17.35 ng/ml (8.1-48.3) (p<0,000). Results of the MEX-SLEDAI score showed significant differences in both groups after the intervention, with a significant decrease in the cholecalciferol group from 2,67 (0-11) to 1,37 (0-6), compared to the placebo group from 2,6 (0-6) to 2,48 (0-6) (p<0,001). There were no significant differences on the quality of life in both groups. Conclusion: Supplementation of cholecalciferol 5000 IU/day for 12 weeks was statistically significant in increasing vitamin D levels and improving disease activity, but did not significantly improve the quality of life of SLE patients.References
Bertsias G RC. SLE pathogenesis and clinical feature. eular-fpp-indd. 2012;36(12):1503.
Olesińska M, Saletra A. Quality of life in systemic lupus erythematosus and its measurement. 2018;45–54.
Buleu F, Gurban C, Sarbu E, et al. The relationship between vitamin D, inflammation and the activity of systemic lupus erythematosus. Fiziol - Physiol. 2015;25(November):87.
Nguyen MH, Bryant K, O’Neill SG. Vitamin D in SLE: a role in pathogenesis and fatigue? A review of the literature. Lupus. 2018;27(13):2003–11.
Antico A, Tampoia M, Tozzoli R, Bizzaro N. Can supplementation with vitamin D reduce the risk or modify the course of autoimmune diseases? A systematic review of the literature. Autoimmun Rev [Internet]. 2012;12(2):127–36.
Christie M, Bartels HSD. Systemic lupus erythematosus (SLE). Medscape [Internet]. 2020;2(2):2319–6718.
Hassanalilou1 T, Khalili L, Ghavamzadeh S, et al. Role of vitamin D defciency in systemic lupus erythematosus incidence and aggravation. Autoimmun Highlights. 2018;9(1):890–4.
Hassanalilou T, Khalili L, Ghavamzadeh S, et al. Role of vitamin D defciency in systemic lupus erythematosus incidence and aggravation. Autoimmun Highlights [Internet]. 2018;9(1):1–10.
Schoindre Y, Jallouli M, Tanguy ML, et al. Lower vitamin D levels are associated with higher systemic lupus erythematosus activity, but not predictive of disease flare-up. Lupus Sci Med. 2014;1(1):1–8.
Rifaâi, Kusworini A, Kusworini HKSW. Effect of vitamin D supplementation on disease activity (SLEDAI) and fatigue in Systemic Lupus Erythematosus patients with hipovitamin D: An Open Clinical Trial. Indones J Rheumatol. 2008;8(2):501–7.
Lomarat W, Narongroeknawin P, Chaiamnuay S, Asavatanabodee P. Randomized double-blind controlled trial to evaluate efficacy of vitamin d supplementation among patients. 2020;7980:24–32.
Fisher SA, Rahimzadeh M, Brierley C, et al. The role of vitamin D in increasing circulating T regulatory cell numbers and modulating T regulatory cell phenotypes in patients with inflammatory disease or in healthy volunteers: A systematic review. PLoS One. 2019;14(9):1–18.
McElhone K, Abbott J, Teh LS. A review of health related quality of life in systemic lupus erythematosus. Lupus. 2006;15(10):633–43.
Lima GL, Paupitz J, Aikawa NE, Takayama L, Bonfa E, Pereira RMR. Vitamin D supplementation in adolescents and young adults with juvenile systemic lupus erythematosus for improvement in disease activity and fatigue scores: a randomized, double-blind, placebo-controlled trial. Arthritis Care Res. 2016;68(1):91–8.
Downloads
Published
How to Cite
Issue
Section
License
Copyright
The authors who publish in this journal agree to the following requirements:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0) that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors can enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) before and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work. (See The Effect of Open Access)
Privacy Statement
The names and email addresses entered in this journal site will be used exclusively for the stated purposes of this journal and will not be made available for any other purpose or to any other party.