Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN) Junior
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Change in vitamin D status
研究概览
简要总结
The main purpose of this study is to investigate whether and in which doses vitamin D intake is needed in order to maintain an adequate vitamin D status in 4-8 year-old Danish children during wintertime.
详细描述
The main objective of ODIN Junior is to investigate whether and in which doses vitamin D intake is needed in order to maintain serum 25(OH)D concentrations above deficiency and insufficiency cut-offs (30 nmol/L and 50 nmol/L, respectively) in 4-8 year-old Danish children during the winter time. The children will be randomized to receive tablets with either 10 micrograms/day or 20 microgram/day of vitamin D3 (cholecalciferol), corresponding to one and two times the recommended daily intake in children, or placebo for 20 weeks. Measurements and blood sampling will be performed before the beginning and by the end of the intervention.
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 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •4-8 years at the start of the intervention
- •of white, Danish/European origin
- •children must be Danish-speaking
- •parents must read and speak Danish
- •not planning a winter vacation south of a latitude of 51°North (corresponding to Surrey, England)
排除标准
- •diseases that may interfere with vitamin D or calcium metabolism
- •intake of medication known to affect vitamin D or calcium metabolism
- •use of vitamin D containing supplements ≥ 4 days/week the last 8 weeks before intervention start and use of any vitamin D containing supplements the last 4 weeks before intervention start
- •concomitant participation in other studies involving dietary supplements or blood sampling
- •serum calcium > 2.7 mmol/L at baseline
结局指标
主要结局
Change in vitamin D status
时间窗: Baseline and 20 weeks
Serum concentrations of total 25-hydroxyvitamin D \[25(OH)D\]
次要结局
- Change in body composition(Baseline and 20 weeks)
- Change in anthropometric measurements(Baseline and 20 weeks)
- Serum calcium(Baseline and 20 weeks)
研究者
Christian Mølgaard
MD, Associate Professor
University of Copenhagen