NCT01765010Unknown4 期
Comparisons of the Effect of Inactive and Active Vitamin D on Serum Sclerostin/dickkopf1 Levels
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change of serum sclerostin level
研究概览
简要总结
The purpose of this study is to compare the effect of inactive and active vitamin D on serum sclerostin and dickkopf1 levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteer older than 20 years
排除标准
- •Subjects with bone and mineral metabolism disorders
- •Subjects with kidney or liver diseases
- •Subjects with uncorrectable hypercalcemia or hypocalcemia
- •Subjects with chronic gastrointestinal disorders or malabsorption
- •Subjects taking medication related to bone loss
研究组 & 干预措施
Placebo control
Placebo Comparator
Placebo control
干预措施: Placebo (Drug)
Cholecalciferol 1000IU
Active Comparator
Cholecalciferol 1000IU qd for 8 weeks
干预措施: Cholecalciferol (Drug)
alfacalcidol
Experimental
alfacalcidol 0.5ug qd for 8 weeks
干预措施: Alfacalcidol (Drug)
Calcitriol
Experimental
Calcitriol 0.25ug qd for 8 weeks
干预措施: Calcitriol (Drug)
结局指标
主要结局
Change of serum sclerostin level
时间窗: 8 weeks later
Change of serum Dickkopf1 level
时间窗: 8 weeks later
次要结局
- Change of serum c-telopeptide level(8 weeks later)
- Change of serum bone-specific alkaline phosphatase level(8 weeks later)
- Change of serum calcium level(8 weeks later)
- Change of serum parathyroid hormone level(8 weeks later)
研究者
研究点 (1)
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