A Randomized, Double-blind, Placebo-controlled Study on Oral Vitamin D Megadoses - 100 000 or 200 000 IU Vitamin D3 Every Three Months
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L
研究概览
简要总结
The purpose of this study is to determine if infrequent administration of oral vitamin D megadoses is effective treatment to maintain serum 25-hydroxyvitamin D(3) above target levels of 50-75 nmol/L. The investigators hypothesize that 100 000 IU or at least 200 000 IU vitamin D3 in every three months would be effective and safe treatment to achieve the target levels.
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, Investigator)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •70-80 yrs old
排除标准
- •disease or medication affecting calcium homeostasis
- •renal failure (Pt-GFRe-CG < 35 ml/min)
研究组 & 干预措施
200 000 IU vitamin D3 every three months
干预措施: vitamin D3 (cholecalciferol) (Dietary Supplement)
100 000 IU vitamin D3 every three months
干预措施: vitamin D3 (cholecalciferol) (Dietary Supplement)
100 000 IU vitamin D3 every three months
干预措施: calcium carbonate (Dietary Supplement)
100 000 IU vitamin D3 every three months
干预措施: olive oil (Other)
200 000 IU vitamin D3 every three months
干预措施: calcium carbonate (Dietary Supplement)
placebo every three months
干预措施: calcium carbonate (Dietary Supplement)
placebo every three months
干预措施: olive oil (Other)
结局指标
主要结局
Serum 25(OH)D3 concentration in relation to the target levels of 50-75 nmol/L
时间窗: 12 months (including 9 time points)
次要结局
- Decline of creatine clearance (Pt-GFRe-CG) >20% from baseline(12 months (including 9 timepoints))
- Hypercalciuria (dU-Ca >10 mmol/24h)(12 months (including 9 timepoints))
- Hypercalcemia (S-Ca-ion >1,3 mmol/l)(12 months (including 9 timepoints))
- Serum PTH(12 months (including 9 timepoints))
- Serum PINP(12 months (including 5 timepoints))
- Serum CTX(12 months (including 5 timepoints))
研究者
Ville-Valtteri Välimäki
MD,PhD
Helsinki University Central Hospital