NCT01633658撤回不适用
The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3 Compared to Native Vitamin D3: A Short Term Pharmacokinetic Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Serum 25(OH)D response
研究概览
简要总结
The investigators hypothesize that native vitamin D will have more variability in 25(OH)D dose response when compared to a given equipotent dose of 25-hydroxyvitamin D3. This will be a single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.
详细描述
Single blind, active control, pharmacokinetic study of 625 μg 25(OH)D given orally or 2500 μg native vitamin D given orally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ten men and women in each group,
- •aged 20-60.
排除标准
- •History of hypercalcemia,
- •vitamin D supplement use > 800 IU daily,
- •BMI > 30,
- •gastrointestinal malabsorption (from celiac sprue, colitis, surgery, etc.), kidney disease or liver disease,
- •use of steroids in any form,
- •anticonvulsants,
- •antibiotics,
- •acute illness, or
- •vacation planned to "sunny climate"
研究组 & 干预措施
25(OH)D
Experimental
A single dose of 625 micrograms 25(OH)D
干预措施: 25(OH)D (Dietary Supplement)
Vitamin D Cholecalciferol
Active Comparator
A single dose of 2500 micrograms cholecalciferol
干预措施: cholecalciferol (Dietary Supplement)
结局指标
主要结局
Serum 25(OH)D response
时间窗: 28 days
25(OH)D will be measured at frequent time intervals over 28 days.
次要结局
未报告次要终点
研究者
研究点 (1)
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