NCT01024777已完成1 期
A Pilot Study to Assess the Relative Safety and Immunology Effects of Low Dose Versus High Dose Cholecalciferol Supplementation in Patients With Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assess safety of high dose cholecalciferol in patients with multiple sclerosis
研究概览
简要总结
The purpose of this study is to determine the safety and the immunologic effects of supplementation with low-dose and high-dose cholecalciferol (vitamin D3) in patients with multiple sclerosis.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between ages of 18-55 years (inclusive)
- •Serum 25(OH) vitamin D levels between 20-50 ng/mL and a candidate for vitamin D supplementation
- •Patients with or without immunomodulatory therapy for RRMS
- •Diagnosis of multiple sclerosis
排除标准
- •Serum 25(OH) vitamin D deficient level < 20 ng/mL
- •High dose vitamin D supplementation in the past 3 months
- •Pregnancy
- •History of tuberculosis, hyperparathyroidism, sarcoidosis or kidney stones
- •Baseline serum creatinine above 1.5
- •Hypersensitivity to vitamin D preparations
- •Milk allergy
- •Unable to consent
研究组 & 干预措施
High dose cholecalciferol
Active Comparator
Patients in the high dose arm will receive 10,000 international units of cholecalciferol daily.
干预措施: Cholecalciferol (Drug)
Low dose cholecalciferol
Active Comparator
Patients enrolled in the low dose arm will receive up to 1000 international units of cholecalciferol daily.
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Assess safety of high dose cholecalciferol in patients with multiple sclerosis
时间窗: 3-6 months
Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis
时间窗: 3-6 months
次要结局
- Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis(6 months)
研究者
Peter A. Calabresi
Professor of Neurology
Johns Hopkins University
研究点 (1)
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