Effect of Vitamin D Supplement on Disease Activity in SLE
NCT ID: NCT05260255
Last Updated: 2025-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2021-06-15
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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vitamin D supplementation
add on vitamin D2 ( calciferol ) 40,000 IU/wk for 12 weeks
vitamin D2 ( calciferol )
add on vitamin D2( calciferol ) 40,000 IU/wk ( 2 cap) for 12 weeks
placebo
add on placebo for 12 weeks
Placebo
add on placebo ( 2 cap ) for 12 weeks
Interventions
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vitamin D2 ( calciferol )
add on vitamin D2( calciferol ) 40,000 IU/wk ( 2 cap) for 12 weeks
Placebo
add on placebo ( 2 cap ) for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* SLE classified by revised ACR criteria, SLICC 2012 criteria
* SLE patients who have mild to moderate disease activity ( clinical SLEDAI-2K 3-10 ) and has vitamin D level \< 40 ng/ml
* currently treated with stable dose of 1 or more of the following background medication : NSAIDs, anti-malarial, MMF, Azathioprine, methotrexate, cyclosporin for at least 1 month, corticosteroid \</= 20 mg/d of prednisolone or equivalent dose for at least 2 weeks
* received calciferol 20,000 IU/wk (1 cap) at least 12 weeks
Exclusion Criteria
* patients who received drug that interfere with vitamin D metabolism
* poor drug compliance
* overlap with other connective tissue disease or a diagnosis of MCTD
* hx of vitamin D allergy
* hx on MTV or other supplementation
18 Years
ALL
Yes
Sponsors
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Department of Medical Services Ministry of Public Health of Thailand
OTHER_GOV
Responsible Party
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Locations
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Rajavithi Hospital
Bangkok, Bangkok, Thailand
Countries
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References
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Ding J, Su S, You T, Xia T, Lin X, Chen Z, Zhang L. Serum interleukin-6 level is correlated with the disease activity of systemic lupus erythematosus: a meta-analysis. Clinics (Sao Paulo). 2020 Oct 19;75:e1801. doi: 10.6061/clinics/2020/e1801. eCollection 2020.
Hassanalilou T, Khalili L, Ghavamzadeh S, Shokri A, Payahoo L, Bishak YK. Role of vitamin D deficiency in systemic lupus erythematosus incidence and aggravation. Auto Immun Highlights. 2017 Dec 26;9(1):1. doi: 10.1007/s13317-017-0101-x.
Aranow C, Kamen DL, Dall'Era M, Massarotti EM, Mackay MC, Koumpouras F, Coca A, Chatham WW, Clowse ME, Criscione-Schreiber LG, Callahan S, Goldmuntz EA, Keyes-Elstein L, Oswald M, Gregersen PK, Diamond B. Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Vitamin D3 on the Interferon Signature in Patients With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2015 Jul;67(7):1848-57. doi: 10.1002/art.39108.
Other Identifiers
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64013
Identifier Type: -
Identifier Source: org_study_id
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