Clinical Trial: Cracking the Egg Potential: Improving Young Child Nutrition in Ecuador
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Cracking the Egg Potential: Improving Young Child Nutrition in Ecuador
Brief Summary: 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.
Detailed Summary:
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.
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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.
- a. Describe existing attitudes, beliefs, and use of eggs in young child diets in Ecuador.
2b. Monitor acceptability and tolerance of daily egg consumption among young children.
2c. Assess willingness of caregivers to prepare and give eggs daily to young children.
BACKGROUND AND SIGNIFICANCE
Globally, 165 million children are affected by stunting arising in part from macro- and micronutrient deficiencies during the complementary feeding period; defined as between 6 and 24 months of age. An estimated 200 million children are not meeting their developmental potential in part because of poor nutrition and, in particular, nutrient intake inadequacies. Eggs provide several of these critical nutrients known to be missing in the diets of young children living in poor countries, yet have been largely underutilized in infant and young child nutrition.
Eggs provide essential fatty acids
Sponsor: Washington University School of Medicine
Current Primary Outcome:
- Serum/plasma concentrations of B12, choline, and betaine [ Time Frame: 6 months ]Venous blood collection
- Serum/plasma concentrations of polyunsaturated fatty acids (PUFAs) and amino acids [ Time Frame: 6 months ]Venous blood collection
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Attitudes, beliefs, and use of eggs in Pastocalle during the complementary feeding period. [ Time Frame: 6 months ]Qualitative assessments: focus groups; in-depth interviews
- Frequency of consumption of eggs, other animal source foods, and dietary diversity more broadly in the child's diet in Pastocalle. [ Time Frame: 6 months ]Household survey
Original Secondary Outcome: Same as current
Information By: Washington University School of Medicine
Dates:
Date Received: February 28, 2015
Date Started: February 2015
Date Completion: January 2017
Last Updated: November 30, 2015
Last Verified: November 2015
