Bioavailability of Vitamin D in Cod Liver Oil and Multivitamin Tablets in Healthy Subjects in Norway
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Difference in delta serum 25-hydroxyvitamin D (nmol/l) between the two parallel intervention groups
研究概览
简要总结
The main aim of the present study is to compare the bioavailability of vitamin D from cod liver oil and multivitamin tablets given to healthy individuals under the same conditions, as well as to study the influence of gender and ethnicity on vitamin D absorption. Healthy subjects will be randomised into two parallel groups receiving 10 micrograms (400 IU) per day of vitamin D3 from one fish oil capsule or one solid multivitamin tablet, respectively. Serum samples will be drawn at baseline and after four weeks (28 days) for the analysis of 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, parathyroid hormone, and tartrate resistant acid phosphatase in serum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •Must be able to meet at baseline and follow-up visit
排除标准
- •Using any vitamin D containing supplements regularly (> once per week)
- •Travelled to sunny countries in the previous 3 months
- •Used a tanning bed in the previous 3 months
结局指标
主要结局
Difference in delta serum 25-hydroxyvitamin D (nmol/l) between the two parallel intervention groups
时间窗: 4 weeks (28 days) between baseline and follow-up visit
次要结局
- Difference in delta 25-hydroxyvitamin D (nmol/l) between ethnic groups(4 weeks (28 days) between baseline and follow-up visit)
- Correlation between change in 25-hydroxyvitamin D (nmol/l) and change in serum intact parathyroid hormone (pmol/l)(4 weeks (28 days) between baseline and follow-up visit)
- Correlation between change in 25-hydroxyvitamin D (nmol/l) and change in serum osteoclast-specific tartrate-resistant acid phosphatase (TRACP 5b); U/l(4 weeks (28 days) between baseline and follow-up visit)
- Difference in delta 25-hydroxyvitamin D (nmol/l) between men and women(4 weeks (28 days) between baseline and follow-up visit)
- Correlation between change in 25-hydroxyvitamin D (nmol/l) and change in serum 1,25-dihydroxyvitamin D (pmol/l)(4 weeks (28 days) between baseline and follow-up visit)
研究者
Haakon E. Meyer
Professor
University of Oslo