Efficacy of a Milk-based Nutrient-rich Bar on Nutritional Status and Cognitive Performance of School Children in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 415
- 试验地点
- 1
- 主要终点
- micronutrient status
研究概览
简要总结
The objective of the study is to evaluate the impact of the milk-based nutrient-rich bar, specifically the effect of its fortification with zinc, iodine, vitamins A and D and calcium on nutritional status of school children, focusing on vitamin A and, zinc, iodine, calcium and iron status, and on their cognitive performances.
详细描述
Design: double-masked randomized control trial Place: three schools in South Vietnam, Can Tho district, South Vietnam Subjects: School children aged 6 to 10 years old, from first grade to third grade of 3 primary schools.
Duration of intervention: 6 months (consumption of Goody or "control bar")
Study groups: 2 groups:
Group 1: children will receive micronutrient enriched milk bar. Group 2: children will receive the same milk-based food except for the micronutrient fortification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pupil in one of the 2 selected schools, in grade 1 - 3
- •weight for height > -3 z-scores
- •hemoglobin concentration > 70 g/L
排除标准
- •weight for height < -3 z-scores
- •hemoglobin concentration <= 70 g/L
结局指标
主要结局
micronutrient status
时间窗: 6 months intervention study with baseline and endpoint data collection
change in micronutrient status (hemoglobin and serum concentrations of vitamin D, calium, zinc) from baseline to end of the intervention when children have received the food bar for 6 months, 5 days/week.
次要结局
- cognitive function(6 months intervention study with baseline and endpoint data collection)
研究者
Frank Wieringa
Senior Researcher
Institut de Recherche pour le Developpement