NCT04909931已完成不适用
Vitamin D Supplementation on Outcome and Disease Activity in Rheumatoid Arthritis Patients At Rajavithi Hospital : a Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To study efficacy of vitamin D on disease activity RA patients at Rajavithi hospital
研究概览
简要总结
To study efficacy of Vitamin D on outcome and disease activity ; DAS28-ESR in Rheumatoid arthritis patients at Rajavithi hospital .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 yrs old
- •RA diagnosed by ACR/EULAR 2010
- •low to moderate disease activity
- •on stable NSAIDs and DMARDs for at least 1 month
- •Received Prednisolone less than or equal to 7.5 mg/day
- •serum calcium, phosphorus and ALP are within normal limit.
排除标准
- •Chronic kidney disease stage 3 or higher
- •History of TB
- •History of Chronic liver disease
- •Pregnancy or breast-feeding
- •adjustment of immuno-suppressive drugs, steroid
- •other connective tissue disease
- •Vitamin D allergy
- •received other drugs which have vitamin D component
- •serum Vitamin D less than 10 ng/mL
研究组 & 干预措施
vitamin D supplementation group
Experimental
First arm ; add on vitamin D 40,000 IU/week for 12 weeks
干预措施: Vitamin D 2 (Drug)
second arm
Experimental
add on placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To study efficacy of vitamin D on disease activity RA patients at Rajavithi hospital
时间窗: 12 weeks
Determine disease activity by DAS28-ESR in relation with vitamin D supplementation.
To study efficacy of vitamin D on IL-6 in RA patients at Rajavithi hospital
时间窗: 12 weeks
DAS-28 ESR measure from swollen joint count, tender joint count, ESR and patient global assessment
次要结局
未报告次要终点
研究者
研究点 (1)
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