Adolescent Girls-Impact of Vitamin D on Bone Accretion Work Package 1 (Danish Part) of OPTIFORD (Towards A Strategy for Optimal Vitamin D Fortification)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Bone turnover measured at baseline, half a year and one year
研究概览
简要总结
Objectives To evaluate the effect of increased vitamin D intake on vitamin D status, bone mass and bone turnover in young girls aged 12-13.
More specifically the effects on the following parameters will be assessed:
- Vitamin D metabolites.
- Parathyroid hormone.
- Bone turnover.
- Bone mineral accretion.
- Serum calcium and phosphate.
- Renal handling of calcium and phosphate.
详细描述
This work package will consist of a randomised double blind one-year vitamin D supplementation study. Primary effect parameter is change in bone mineral content and therefore study duration will be one year. A total of 225 subjects, 75 in each of the three groups: one control and two intervention groups, will be included Two dosages of supplementation will be used: 5 µg per day and 10 µg per day.
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
- Double
入排标准
- 年龄范围
- 10 Years 至 11 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Girls born in Denmark with Danish citizenship aged 10.0-11.0 years living in the municipals of Copenhagen and Frederiksberg
排除标准
- •Any chronical disease with influence on bone mass or turnover
- •Intake of drugs with influence on bone mass or turnover
- •Intake of calcium or vitamin D other than the intervention
结局指标
主要结局
Bone turnover measured at baseline, half a year and one year
Vitamin D level (status) measured as s-25 hydroxy vitamin D at baseline, after half a year and one year.
Bone accretion measured by DXA. Measurement at baseline and after one year.
次要结局
未报告次要终点