Safety and Bioefficacy of Vitamin D2 and Vitamin D3: Randomized Trial With Human Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- change of 25-hydroxvitamin D
研究概览
简要总结
The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively, and by total 25(OH)D.
详细描述
Study design: Human volunteers will receive supplements containing either vitamin D2 or D3 for a period of 8 weeks. At baseline, after 4 weeks and after 8 weeks, 25(OH)D2, 25(OH)D3 and total 25(OH)D will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum, ambulatory blood pressure and heart rate, and renin expression in peripheral mononuclear cells.
Groups/Cohorts Assigned Interventions
- Placebo group
- Vitamin D2-group Daily treatment with vitamin d2-supplements (containing 2000 IU per capsule)
- Vitamin D3-group Daily treatment with vitamin d3-supplements (containing 2000 IU per capsule)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（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
- •supplementation of vitamin d and calcium
- •hypercalcemia
- •hypercalciuria
- •chronical illness (diabetes, kidney diseases, cardiovascular diseases)
- •serum-creatinine above 115 mmol/l
- •pregnancy or breastfeeding women
结局指标
主要结局
change of 25-hydroxvitamin D
时间窗: after 4 and 8 weeks of supplementation
次要结局
未报告次要终点
研究者
Ulrike Lehmann
Principal Investigator
Martin-Luther-Universität Halle-Wittenberg