Bioefficiency of of Conventional Fish and Vitamin D Fortified Fish in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 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 conventional and vitamin D fortified fish as measured by the increase of the specific hydroxy form by 25(OH)D3.
详细描述
Study design: Human volunteers will receive conventional fish or vitamin D fortified fish for a period of 4 weeks. At baseline and after 4 weeks, 25(OH)D3 will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum.
Groups/Cohorts Assigned Interventions
- Placebo group receiving conventional fish
- intervention group receiving vitamin D fortified fish
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 —（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
研究组 & 干预措施
vitamin D fortified fish
Human volunteers receiving vitamin D fortified fish, 4 weeks
干预措施: vitamin D fortified fish (Other)
conventional fish
consumption of conventional fish , 4 weeks
干预措施: conventional fish (Other)
结局指标
主要结局
change of 25-hydroxvitamin D
时间窗: after 4 weeks of consumption
次要结局
未报告次要终点
研究者
Ulrike Lehmann
Scientist
Martin-Luther-Universität Halle-Wittenberg