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临床试验/NCT00944398
NCT00944398已完成4 期

Evaluation of the Use of Plasma Zinc Concentration for Assessing the Impact of Targeted and Mass Zinc Fortification Programs

University of California, Davis1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
98
试验地点
1
主要终点
Plasma zinc concentration

研究概览

简要总结

The purpose of the study is to evaluate the use of plasma zinc concentration for assessing the impact of targeted zinc fortification programs.

详细描述

The objectives of the present study are to determine whether plasma zinc concentration changes in response to additional zinc consumption, as provided by zinc-fortified cereal-based complementary foods fed to young children. The following specific steps will be completed:

  1. Zinc-fortified complementary foods and breads prepared from zinc-fortified cereal flours will be developed with assistance from experts in food technology.
  2. A two-week feeding trial will be implemented to assess the change in plasma zinc concentration among young children who receive: a) the zinc-fortified cereal porridge and a liquid vitamin preparation between meals; b) a non-zinc-fortified cereal porridge and a liquid vitamin preparation between meals [negative control group]; or c) a non-zinc-fortified cereal porridge and a zinc-containing liquid vitamin preparation between meals [positive control group].

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
12 Months 至 17 Months(Child)
性别
All
接受健康志愿者

入选标准

  • apparently healthy

排除标准

  • severe malnutrition
  • severe anemia

结局指标

主要结局

Plasma zinc concentration

时间窗: 3 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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