Study on the Effects of a Recommendation Based Supply of Vitamin D3 in Healthy Volunteers - a Randomized Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- 25-hydroxyvitamin D3
研究概览
简要总结
The aim of this study is to investigate whether a supplementation of 20 µg Vitamin D3 per day for 12 weeks can be used to normalize vitamin d-Status
详细描述
It is the objective of this study to investigate whether a supplementation with Vitamin D3 can be used to normalize insufficient vitamin d status and reduce atherosclerotic risk factors such as hypertension, inflammation and hyperlipidemia. The research question is whether Vitamin D3 reduces the level of systemic inflammation and whether Vitamin D3 has an effect on blood lipids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers
- •age between 18 and 70 years
- •informed consent
排除标准
- •use of antihypertensive medication
- •use of vitamin d or calcium supplements
- •known renal, inflammatory or malignant diseases
- •hypercalcemia or hypercalciuria
- •participation in other clinical studies
- •use of tanning booths during the study
- •pregnancy or lactating period
结局指标
主要结局
25-hydroxyvitamin D3
时间窗: after 12 weeks of supplementation
major outcome variable is the increase of 25-hydroxyvitamin D3 in the treatment group in comparison with the placebo group
次要结局
- atherosclerotic risk factors(after 12 weeks of supplementation)
- inflammation(after 12 weeks of supplementation)
- hyperlipidemia(after 12 weeks of supplementation)
研究者
Ulrike Lehmann
Principal Investigator
Martin-Luther-Universität Halle-Wittenberg