Vitamin Therapy in Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Disease Activity Score (DAS) 28
研究概览
简要总结
The purpose of this study is to investigate the effect of vitamin D repletion on disease activity and disability in patients with rheumatoid arthritis.
The investigators hypothesize that rheumatoid arthritis (RA) patients with vitamin D deficiency have greater disease activity and disability, compared to RA patients with normal vitamin D levels. The investigators also hypothesize that vitamin D treatment in these deficient patients will result in a decrease in RA disease activity and disability.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid Arthritis diagnosed according to American College of Rheumatology (ACR) criteria
- •ages 18-75 years
排除标准
- •Diagnosis of any other autoimmune disease:
- •such as Lupus, Scleroderma, Myositis, Sjogren's Syndrome, Vasculitis'
- •Having any of the following conditions with in the last 6 months Hypercalcemia, Hyperparathyroidism, Active tuberculosis (TB), Lymphoma or any other type of cancer, Sarcoidosis, Seizure, Stroke
- •Severe heart problems
- •Kidney failure requiring dialysis treatment
- •Liver failure or cirrhosis of the liver
- •Poorly controlled hypertension
- •current uncontrolled Depression, Bipolar Disorder, or other Psychiatric illness
- •Pregnancy
研究组 & 干预措施
placebo group
RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.
Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.
干预措施: Placebo sugar pill (Drug)
placebo group
RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.
Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.
干预措施: Ergocalciferol (Drug)
Ergocalciferol
Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.
干预措施: Ergocalciferol (Drug)
结局指标
主要结局
Disease Activity Score (DAS) 28
时间窗: Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))
We measured disease activity as measured by DAS 28 at baseline and at the completion of Randomized Controlled trial, both in the placebo and the active treatment group. We used DAS-28 scores to indicate disease activity. The DAS -28 scale has a minimum of 0 and a maximum of 10, with higher numbers indicating higher disease activity. We used the following cut-offs: Remission (\< 2.6), low disease activity (\< 3.2), moderate disease activity (\< 5.1) and high disease activity (\> 5.1).
次要结局
- Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF)(Baseline and 16 weeks (end of RCT))