临床试验/NCT05260255

NCT05260255已完成不适用

The Effect of Vitamin D Supplementation on Disease Activity of Systemic Lupus Erythematosus Patients: a Randomized Clinical Trial in Rajavithi Hospital

Rajavithi Hospital1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2021年6月15日最近更新: 2025年1月6日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Rajavithi Hospital
入组人数: 100
试验地点: 1
主要终点: To examine the effect of vitamin D supplementation on SLE disease activity

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•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

排除标准

•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

研究组 & 干预措施

placebo

Placebo Comparator

add on placebo for 12 weeks

干预措施: Placebo (Drug)

vitamin D supplementation

Experimental

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

干预措施: vitamin D2 ( calciferol ) (Drug)

结局指标

主要结局

To examine the effect of vitamin D supplementation on SLE disease activity

时间窗: 12 weeks

Study the SLE disease activity by SLEDAI-2K in relation with vitamin D levels

次要结局

To determine adverse reaction of high dose vitamin D(12 weeks)
To study the effect of vitamin D supplementation on anti-dsDNA titer(12 weeks)
To determine whether IL-6 can early detection in SLE disease flare(12 weeks)
To examine the effect of vitamin D supplementation on IL-6 level(12 weeks)

研究者

发起方

Rajavithi Hospital

申办方类型

Other Gov

责任方

Sponsor

研究点 (1)

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