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临床试验/NCT00589264
NCT00589264已完成不适用

Zinc and Biobehavioral Development in Early Childhood

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2004年7月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura Caulfield

Professor

Johns Hopkins Bloomberg School of Public Health

研究点 (1)

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