NCT01415557已完成不适用
The Effects of Regular Consumption of a Multiple Micronutrient Fortified Beverage on the Micronutrient Status of Indian Schoolchildren and on Their Mental and Physical Performance
Mondelēz International, Inc.2 个研究点 分布在 1 个国家目标入组 227 人开始时间: 2011年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 227
- 试验地点
- 2
- 主要终点
- Change from baseline in the micronutrient status in the study subjects at 6 months
研究概览
简要总结
The purpose of this study is to assess the impact of regular consumption of micronutrient fortified drink in improving nutritional and micronutrient status in Indian school children. The test beverage will be fortified with both, vitamins and minerals.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy school going children
- •not severely malnourished weight-for-height z-score ≥-2 not severely anemic (Hb<8g/dl)
- •Age: 7-10 years
- •Not taking any food supplements/fortified drinks
- •Not planning to move out during the study duration
排除标准
- •Age: <7 and >10 years
- •Severe anemia (Hb < 8 g/dl)
- •Severely malnourished children with weight-for-height z-score <-3 will be excluded.
- •Cardiovascular disease on clinical examination or history
- •Underlying respiratory disease with impairment of lung function
- •Physical disability which can interfere or limit performance of tests
- •Recent history (3 months prior) of serious infections, injuries and/ or surgeries
- •Any food allergy or food intolerance
- •Participation in any nutritional study in the last 1year
- •Children consuming nutritional supplements and/ or health food drinks
结局指标
主要结局
Change from baseline in the micronutrient status in the study subjects at 6 months
时间窗: 6 months
The primary outcome measures will be change from baseline in the micronutrient status in the study subjects at end of intervention.
次要结局
- Change from baseline in cognitive performance at 6 months(6 months)
- Change from baseline in the physical performance at 6 months(6 months)
- Change from baseline in the fatigue score at 6 months(Baseline and Endline (six months))
- Morbidity Assessment(6 months)
- Prevalence of Micronutrient Deficiency(6 months)
- Change from baseline in anthropometric scores at 6 months(6 months)
研究者
研究点 (2)
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