Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 597
- 主要终点
- Serum 25-hydroxyvitamin D Concentrations in Schoolchildren
研究概览
简要总结
This intervention study will address the impact of vitamin D fortified milk and vitamin D supplements on the growth, levels of vitamin D, insulin-like growth factor 1, growth hormone, academic attention, respiratory infections, asthma, and flexural dermatitis (a proxy for eczema) of Mongolian children.
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 9 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children in 3rd and 4th grade from selected Mongolian schools.
- •School selection will consider:
- •socioeconomic position;
- •geographic location;
- •school size;
- •current lunch or supplementation program; and
- •the interest and willingness to participate of the school's administration and faculty.
排除标准
- •Allergy to milk or wheat products.
研究组 & 干预措施
1
Mongolian milk without D
干预措施: Mongolian milk without vitamin D (Dietary Supplement)
2
Mongolian milk with vitamin D
干预措施: Mongolian milk with vitamin D (Dietary Supplement)
3
Ultra High Temperature (UHT) milk
干预措施: UHT milk (Dietary Supplement)
5
Seasonal D
干预措施: Seasonal D supplement (Dietary Supplement)
4
Milk Substitute
干预措施: Milk Substitute (Dietary Supplement)
6
Daily D
干预措施: Daily D supplement (Dietary Supplement)
结局指标
主要结局
Serum 25-hydroxyvitamin D Concentrations in Schoolchildren
时间窗: Blood was analyzed at day 0 and day 49
Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry
次要结局
未报告次要终点
研究者
Janet Rich-Edwards
Direct of Developmental Epidemiology
Brigham and Women's Hospital