NCT00952562已完成不适用
The Influence of Vitamin D on Mineral Metabolism, Blood Pressure and Pulse Wave Analysis in Healthy Individuals. A Randomised Double Blinded Placebo Controlled Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- urinary calcium excretion
研究概览
简要总结
A randomized placebo controlled trial evaluating the effect of the recently recommended high doses of cholecalciferol (3000 IU/day) on mineral metabolism, blood pressure and pulse wave analysis in healthy individuals.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 18 years old
- •p 25OH vitaminD<50nmol/l
- •signed informed consent
排除标准
- •receiving antihypertensive or antidiabetic treatment
- •sarcoidoses
- •history of kidney stones
- •receiving 1-alfa-hydroxylated vitamin D treatment
- •plasma creatinin > 120 micromol/l
- •ionised calcium > 1,5 mmol/l
- •treatment with calcimimetics
- •active malignancy
- •intestinal malabsorption
- •active pancreatitis
- •former hospitalisation due to alcoholic related disease
- •using euphoriant drugs
- •pregnancy or risk of being pregnant or lactating women
- •Known allergy to cholecalciferol capsules
结局指标
主要结局
urinary calcium excretion
时间窗: before and after 16 weeks of intervention
次要结局
- 25 hydroxyvitamin D(before and after 16 weeks og treatment)
- 1,25 dihydroxyvitamin D(before and after 16 weeks of treatment)
- urinary creatinin(before and after 16 weeks of treatment)
- urinary protein(before and after 16 weeks of treatment)
- urinary phosphorous(before and after 16 weeks of treatment)
- p-FGF23(before and after 16 weeks of treatment)
- blood pressure(before and after 16 weeks of treatment)
- pulse wave velocity(before and after 16 weeks of treatment)
- augmentation index(before and after 16 weeks of treatment)
- central blood pressure(before and after 16 weeks of treatment)
- p-phosphate(before and after 16 weeks of treatment)
- ionised p-calcium(before and after 16 weeks of treatment)
- p-iPTH(before and after 16 weeks of treatment)
- alkalic phosphatase(before and after 16 weeks of treatment)
研究者
研究点 (2)
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