Zinc Bioavailability From Amaranth-enriched Maize Tortillas

Not Applicable

Completed

• Conditions: Nutritional Deficiency
• Interventions: Other: Day 2 Maize Tortillas without 20% Amaranth

• Registration Number: NCT02208609
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Maize Tortillas without 20% Amaranth	Day 2 Maize Tortillas without 20% Amaranth	Children in this arm were fed maize tortillas without amaranth

Primary Outcome Measures

Name	Time	Method
Zinc Absorption	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).

Trial Locations

Locations (2)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Universidad Francisco Marroquin; 🇬🇹 Guatemala City, Guatemala