Efficacy of Zn Biofortified Wheat in Improving Zn Status in Indian School Children With Low Zn Status: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Change of plasma zinc values from baseline to endpoint and two months post intervention
研究概览
简要总结
The objective of this research is to test the efficacy of Zn biofortified wheat in increasing Zn status in Indian school children aged 6-12 y via a 6 month randomized controlled trial.
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 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •generally healthy
排除标准
- •unhealthy
研究组 & 干预措施
Control
Control wheat used for meal, level of zinc is usual
干预措施: Control (Dietary Supplement)
fortification
Fortification Wheat is fortified before testmeal administration. Zinc level is comparable to WHO recommendation
干预措施: Fortification (Dietary Supplement)
Biofortified
Biofortification Biofortified wheat is used for testmeal administration. Zinc concentration is around 30% higher than control
干预措施: Biofortified wheat (Dietary Supplement)
结局指标
主要结局
Change of plasma zinc values from baseline to endpoint and two months post intervention
时间窗: day 0, random between day 0 and 6 month, 6 month and random between 6 months and 2 months post-intervention
plasma zinc will be measured at baseline, midpoint (random sparse sampling), endpoint (6 months) and randomly within two months post-intervention
次要结局
- Change in the Inflammation marker from baseline to the end of the intervention, as well as post-intervention(day 0, random during the intervention, month 6, and random 2 months post intervention)
- Change in the chronic inflammation marker from baseline to 6 months and 2 month post intervention(day 0, random during the intervention, month 6, and random 2 months post intervention)
- Change in Iron status from baseline to the end of the intervention and 2 months post-intervention(day 0, random during the intervention, month 6, and random 2 months post intervention)
- Change in Iron status from baseline to the end of intervention, and within two months post-intervention(day 0, random during the intervention, month 6, and random 2 months post intervention)
- New Zn biomarkers(day 0, random during the intervention, month 6, and random 2 months post intervention)
- New potential Zn biomarkers in buccal cells(day 0, random during the intervention, month 6, and random 2 months post intervention)
- Characterization of gut microflora(baseline, endpoint (6 months))
- Anthropometry(baseline (day 0), endpoint (6 months))
- morbidity(throughout the study)
研究者
Prof. Michael B. Zimmermann
Prof
Swiss Federal Institute of Technology