Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena? A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2
研究概览
简要总结
Several studies have demonstrated that D2 treatment is associated with a decrease in 25(OH)D3 level and therefore have proposed that D3 would be preferable in term of raising total 25(OH)D level. The investigators postulate that the D2 treatment-associated decrease in 25(OH)D3 level may be related to an increase in total 25(OH)D level rather than being specific to D2 treatment, and thus there would be a D3 treatment-associated decrease in 25(OH)D2 level.
The investigators plan to conduct a double-blind placebo-controlled trial to examine the effect of D3 treatment on 25(OH)D2 level and the effect of D2 treatment on 25(OH)D3 leve
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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
Group-2-D3
Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to vitamin D3
干预措施: Vitamin D3 (Drug)
Group-2-D3
Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to vitamin D3
干预措施: Vitamin D2 (Drug)
Group-2-Placebo
Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to placebo oral capsule.
干预措施: Vitamin D2 (Drug)
Group-2-Placebo
Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to placebo oral capsule.
干预措施: Placebo oral capsule (Drug)
Group-1-D2
Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less= 65 nmol/l will be randomly assigned to vitamin D2.
干预措施: Vitamin D2 (Drug)
Group-1-Placebo
Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less =65 nmol/l will be randomly assigned to placebo oral capsule.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2
时间窗: day 28
ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1
时间窗: day 28
次要结局
- Pearson correlation between changes in 25(OH)D2 level in the active arm of group-2 and baseline total 25(OH)D level(day 28)
- Pearson correlation between changes in 25(OH)D3 level in the active arm of group-1 and baseline total 25(OH)D level(day 28)
- Pearson correlation between changes in 25(OH)D3 level and 25(OH)D2 level in the active arm of each group(day 28)
- ANCOVA-adjusted, mean D2-induced change in 25(OH)D3 level group-1(day 56)
- ANCOVA-adjusted, mean D3-induced change in 25(OH)D2 level in group-2(day 56)