Effects of Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Onset Systemic Lupus Erythematosus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change in Disease Activity Score (SLEDAI)
研究概览
简要总结
The potential role of vitamin D on disease susceptibility, activity and severity has been considered for several autoimmune rheumatologic diseases include systemic lupus erythematosus (SLE) . Although, there are few studies of vitamin D supplementation in SLE patients, especially in Juvenile Onset Systemic Lupus Erythematosus (JoSLE).
The objective of this study is to evaluate the effect of vitamin D supplementation (cholecalciferol 50.000 international units (IU)/week for 24 weeks) on disease activity (clinical and laboratory parameters), fatigue and bone mass.
详细描述
This is a study 24-week, two arm, double blinded randomized clinical trial to evaluate the effects of high-dose vitamin D3 supplementation compared with placebo, on activity disease, fatigue and bone mass.
Sixty JoSLE patients will be randomized to receive placebo or vitamin D3 (50.000 IU/week) for 24weeks. The patients return to visits in week 12 and week 24 for evaluation. Study will record clinical history, drugs in use, disease activity, and bone mass parameters.
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
- 10 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent signed
- •4 of the 11 modified American College of Rheumatology (ACR) Revised Criteria for the Classification of Systemic Lupus Erythematosus .
- •SLEDAI < 8 at Screening and at Baseline
- •Stable immunosuppressive dose prior to randomization.
- •Body Mass Index < 30
- •Able to swallow pills at randomization
排除标准
- •Refuse of the patient or the legal responsible
- •Use of vitamin D2 or D3 supplementation
- •Significant renal insufficiency
- •Primary hyperparathyroidism (known)
- •History of nephrolithiasis (known)
- •Diabetes mellitus requiring insulin therapy
- •History of vertebral compression fractures (known)
- •Pregnancy
- •Use of bisphosphonates
研究组 & 干预措施
Cholecalciferol 50.000IU/week
patients will receive vitamin D3 (50.000 IU/week) for 24weeks
干预措施: Cholecalciferol (Drug)
Placebo
patients receive placebo in similar capsules of cholecalciferol for 24weeks
干预措施: Placebo (Drug)
结局指标
主要结局
The change in Disease Activity Score (SLEDAI)
时间窗: baseline to week 12 and 24
次要结局
- The change in Fatigue Score(baseline to week 12 and 24)
- The change in Bone Mineral Parameters(baseline to week 12 and 24)
研究者
ROSA MARIA RODRIGUES PEREIRA
Associate Professor
University of Sao Paulo