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临床试验/NCT02208609
NCT02208609已完成不适用

Absorption of Zinc (Zn) From Traditional Maize Tortillas and Amaranth-enriched Tortillas by Toddlers in the Indigenous Post-Mayan Population

University of Colorado, Denver3 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2012年1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
20
试验地点
3
主要终点
Zinc Absorption

研究概览

简要总结

Young children in Guatemala are at risk for nutrient deficiencies due to plant-based diets and poor sanitation. Stunting, frequent diarrhea, and respiratory infections are common. Supplementation of Zn to children during diarrhea episodes has been shown to diminish duration and severity of illness. Poor Zn absorption due to high fiber and phytate in this diet might play a role in these processes. Supplementation of this micronutrient in the diet might be beneficial. The investigators will compare absorption of Zn from white maize tortillas enriched with 20% amaranth to traditional white corn tortillas in preschool children in Guatemala.

详细描述

This is a randomized cross-over study of zinc absorption in young children living in the Western Highlands of Guatemala. Absorption of zinc will be measured from maize tortillas and maize tortillas fortified with 20% amaranth as the major food staple which provides at least 70% energy and at least 90% zinc and phytate of the diet. Participants will be randomized as to which type of tortilla they receive on the first and second day. Fractional absorption of zinc (FAZ) from all meals in one day for one type of tortilla and one day for the other will be measured by extrinsic labeling with stable isotopes of zinc. FAZ will be measured by a dual isotope tracer ratio (DITR) technique based on ratio of urine enrichment of orally versus intravenously administered zinc stable isotopes. Measurement of total zinc in duplicate diets on test days allow for determination of quantities of this micronutrient absorbed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 2-3 years of age
  • apparently healthy
  • eats >2-3 tortillas at each meal of the day.

排除标准

  • Chispitas or macrovital supplementation
  • breastfeeding
  • birth weight < 2,500 g
  • birth defect affecting growth and development
  • chronic infection
  • twin or triplet
  • sibling enrolled in study

结局指标

主要结局

Zinc Absorption

时间窗: 2 days

Absorption of zinc will be compared in young children when fed the common maize tortilla and a tortilla fortified with 20 % amaranth.. Fractional absorption of zinc for a day will be measured by extrinsic labeling with stable isotopes of zinc. Fractional absorption of zinc will be measured by a dual isotope tracer ratio technique. Measurement of total zinc in duplicate diets on test day will allow determination of quantity of this micronutrient absorbed (mg/d).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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