Evaluation of the Use of Plasma Zinc Concentration for Assessing the Impact of Targeted and Mass Zinc Fortification Programs
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:
- Zinc-fortified complementary foods and breads prepared from zinc-fortified cereal flours will be developed with assistance from experts in food technology.
- 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
- 是
入选标准
- •apparently healthy
排除标准
- •severe malnutrition
- •severe anemia
研究组 & 干预措施
Zinc fortified group
Daily consumption of zinc-fortified complementary food
干预措施: Zinc fortified food (Dietary Supplement)
Zinc fortified group
Daily consumption of zinc-fortified complementary food
干预措施: Placebo supplement (Other)
Non-fortified group
Daily consumption of non-fortified complementary food and placebo supplement.
干预措施: Placebo supplement (Other)
Non-fortified group
Daily consumption of non-fortified complementary food and placebo supplement.
干预措施: Non-fortified food (Dietary Supplement)
Zinc supplement group
Daily consumption of zinc supplement and non-fortified complementary food.
干预措施: Non-fortified food (Dietary Supplement)
Zinc supplement group
Daily consumption of zinc supplement and non-fortified complementary food.
干预措施: Zinc supplement (Dietary Supplement)
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