The Effect of Vitamin D Fortification of Bread and Milk in Danish Families
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 782
- 试验地点
- 1
- 主要终点
- serum 25-hydroxyvitamin D
研究概览
简要总结
Approximately 200 families corresponding to 800 persons are included in the study. The study investigate the efficacy of vitamin D fortification of bread and milk on vitamin D status in serum. Participants receive milk and bread twice a week. Half of the participants receive vitamin D fortified products and the other half similar non-fortified products. The study starts in September and runs for 6 months during winter, the period where it is not possible to produce vitamin D in the skin through sunlight exposure. The hypothesis is that the usual fall in vitamin D status can be prevented by vitamin D fortified food.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Family with at least one child between the age 4 to 18 years and at least one adult less than 60 years of age
- •Permanent address in a specific geographical region.
排除标准
- •Use of medication (including dietary supplements with high levels of vitamin D)
- •Diseases which influence vitamin D metabolism
- •Pregnancy
研究组 & 干预措施
Vitamin D fortified bread and milk
干预措施: Vitamin D fortification (Other)
Non-fortified bread and milk
结局指标
主要结局
serum 25-hydroxyvitamin D
时间窗: 6 months
serum 25-hydroxyvitamin D is measured at the start of the study, after 2-3 months (on adults only) and after approximately 6 months
次要结局
未报告次要终点