NCT00718276已完成1 期
Pharmacokinetic Study in Healthy Postmenopausal Women to Compare Supplementation of Vitamin D3 to 25(OH)D
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
- 35
- 试验地点
- 1
- 主要终点
- serum 25(OH)D levels
研究概览
简要总结
We compare the effect of HyD (25-hydroxyvitamin D) and vitamin D3 in their effect on 25-hydroxyvitamin D plasma levels over a course of 4 month. This is a pharmacokinetic study including 35 postmenopausal women.
- Trial with medicinal product
详细描述
We include postmenopausal women age 50 to 75, race/ethnicity: Caucasian, serum 25(OH)D at baseline between 20 to 60 nmol/l, body mass index: < 30 kg/m2
to compare 25(OH)D and vitamin D3 in equimolar doses over a 4 month pharmacokinetic trial. The dosing arms are daily, weekly, and bolus
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Active Comparator
25(OH)D
干预措施: 25(OH)D (Drug)
2
Active Comparator
vitamin D3
干预措施: vitamin D3 (Dietary Supplement)
结局指标
主要结局
serum 25(OH)D levels
时间窗: repeated assessments over 4 months
次要结局
- muscle strength, blood pressure, blood glucose, bone markers(repeated assessments over 4 months)
研究者
研究点 (1)
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