Effect of Vitamin D Supplement on Disease Activity in SLE (NCT05260255) | Clinical Trial Compass
CompletedNot Applicable
Effect of Vitamin D Supplement on Disease Activity in SLE
Thailand100 participantsStarted 2021-06-15
Plain-language summary
To study the effect of vitamin D supplementation on disease activity of SLE ( SLEDAI-2K ) and IL-6 level
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 18 year-old
* 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 with chronic liver disease, CKD stage 3, bed ridden, malignancy
* 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
What they're measuring
1
To examine the effect of vitamin D supplementation on SLE disease activity
Timeframe: 12 weeks
Trial details
NCT IDNCT05260255
SponsorDepartment of Medical Services Ministry of Public Health of Thailand