Zinc and Biobehavioral Development in Early Childhood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- cognitive development(visual attention, executive processing, vigilance)
研究概览
简要总结
Zinc is necessary for growth and development, including the central nervous system, and zinc deficiency which is common in resource-poor settings, may adversely affect social, behavorial, cognitive and sensorimotor development. The project, located in Lima Peru, utilizes an experimental model in which children receive 10 mg supplemental zinc (or not) daily along with 10 mg iron and 1/2 mg copper from 6 months of age to 18 months of age. Beginning at 6 months of age, and at 9, 12, and 18 months, children are evaluated in multiples aspects of development. Children are also followed for their diet, growth, and health status. We hypothesize that children in this setting in which the diet is low in zinc who receive supplemental zinc will have better information processing skills, sensorimotor and behavioral development than their counterparts who do not receive supplemental zinc.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 18 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Born at term of non-low birth weight
- •Free of major malformations, genetic abnormalities or health problems associated with developmental delays
- •Planning to remain in study area for one year
- •In good general health
排除标准
- •Low birth weight
- •Non-term delivery
- •Vision or hearing problems
结局指标
主要结局
cognitive development(visual attention, executive processing, vigilance)
时间窗: 6, 9, 12, and 18 months
次要结局
未报告次要终点
研究者
Laura Caulfield
Professor
Johns Hopkins Bloomberg School of Public Health
