Clinical Trials Directory

Trials / Completed

CompletedNCT02208609

Zinc Bioavailability From Amaranth-enriched Maize Tortillas

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
University of Colorado, Denver · Academic / Other
Sex
All
Age
18 Months – 36 Months
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERDay 1: Maize Tortillas with 20% AmaranthSubjects received Maize tortillas with 20% Amaranth added.
OTHERDay 2 Maize Tortillas without 20% AmaranthMaize tortillas without Amaranth.

Timeline

Start date
2012-01-01
Primary completion
2015-12-01
Completion
2015-12-01
First posted
2014-08-05
Last updated
2016-04-29

Locations

2 sites across 2 countries: United States, Guatemala

Source: ClinicalTrials.gov record NCT02208609. Inclusion in this directory is not an endorsement.