Effect of Vitamin D Supplement on Disease Activity in SLE

Rajavithi Hospital

Status: Completed

Conditions: Vitamin D Deficiency; Hyperparathyroidism; Hypocalcemia; Systemic Lupus Erythematosus (Disorder)

Treatments: Drug: Placebo; Drug: vitamin D2 ( calciferol )

Study type: Interventional

Funder types: Other

Identifiers

NCT05260255

64013

Details and patient eligibility

About

To study the effect of vitamin D supplementation on disease activity of SLE ( SLEDAI-2K ) and IL-6 level

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

vitamin D supplementation

Experimental group

Description:

add on vitamin D2 ( calciferol ) 40,000 IU/wk for 12 weeks

Treatment:

Drug: vitamin D2 ( calciferol )

placebo

Placebo Comparator group

Description:

add on placebo for 12 weeks

Treatment:

Drug: Placebo