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临床试验/NCT02446873
NCT02446873已完成不适用

Cracking the Egg Potential: Improving Young Child Nutrition in Ecuador

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2015年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
171
试验地点
1
主要终点
Serum/plasma concentrations of polyunsaturated fatty acids (PUFAs) and amino acids

研究概览

简要总结

The proposed study will fill an important gap in the literature by examining, through a randomized controlled trial, the effect of egg consumption on biochemical markers of choline, vitamin B-12, lipids, and amino acids in young children in a poor rural area of Ecuador. Children from Cotopaxi Province, Ecuador (n=180) will be randomized into one of two groups: 1) intervention, receiving one egg per day for six months; or 2) control. Baseline and endline data on socio-economic factors, and child diet, morbidities, and anthropometry will be collected. Blood will also be drawn from the children at these time points for nutrient biomarker analyses. Through qualitative research the proposed study will provide insight into the attitudes, beliefs, and use of eggs by mothers and other caregivers during the complementary feeding period. The University of San Francisco in Quito (USFQ) will be the lead field coordinator of the research working in partnership with Washington University in St. Louis, Pan-American Health Organization (PAHO) and University of California, Davis.

详细描述

OBJECTIVES

Objective 1: Test the efficacy daily egg consumption for six months on the macro- and micronutrient status of young children from an indigenous community in Ecuador.

1a. Measure serum concentration of micronutrient biomarkers: choline; betaine; and vitamin B12.

  1. b. Measure serum concentrations of macronutrient biomarkers: lipids (total free and esterified); and amino acids.

Objective 2: Characterize attitudes, beliefs, and use of eggs during the complementary feeding period. 2. a. Describe existing attitudes, beliefs, and use of eggs in young child diets in Ecuador.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 9 Months(Child)
性别
All
接受健康志愿者

入选标准

  • child is healthy and between the age of 6 months to 9 months

排除标准

  • age of child
  • any reactions to eating to eggs, a rash, hives, difficulty breathing

研究组 & 干预措施

Treatment

Experimental

Egg supplementation

干预措施: Egg supplementation (Other)

Control

No Intervention

Control group

结局指标

主要结局

Serum/plasma concentrations of polyunsaturated fatty acids (PUFAs) and amino acids

时间窗: 6 months

Venous blood collection

Serum/plasma concentrations of B12, choline, and betaine

时间窗: 6 months

Venous blood collection

次要结局

  • Frequency of consumption of eggs, other animal source foods, and dietary diversity more broadly in the child's diet in Pastocalle.(6 months)
  • Attitudes, beliefs, and use of eggs in Pastocalle during the complementary feeding period.(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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