Zinc Bioavailability From Amaranth-enriched Maize Tortillas

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT02208609

Collaborator

International Atomic Energy Agency (Other), Universidad Francisco Marroquín (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nutritional Deficiency	Other: Day 1: Maize Tortillas with 20% Amaranth Other: Day 2 Maize Tortillas without 20% Amaranth	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Official Title:

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Maize Tortillas with 20% Amaranth Children in this arm were fed maize tortillas fortified with 20% amaranth	Other: Day 1: Maize Tortillas with 20% Amaranth Subjects received Maize tortillas with 20% Amaranth added.
Experimental: Maize Tortillas without 20% Amaranth Children in this arm were fed maize tortillas without amaranth	Other: Day 2 Maize Tortillas without 20% Amaranth Maize tortillas without Amaranth.

Arm

Intervention/Treatment

Experimental: Maize Tortillas with 20% Amaranth

Children in this arm were fed maize tortillas fortified with 20% amaranth

Other: Day 1: Maize Tortillas with 20% Amaranth

Subjects received Maize tortillas with 20% Amaranth added.

Experimental: Maize Tortillas without 20% Amaranth

Children in this arm were fed maize tortillas without amaranth

Other: Day 2 Maize Tortillas without 20% Amaranth

Maize tortillas without Amaranth.

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 36 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80045
2	Universidad Francisco Marroquin	Guatemala City		Guatemala

Sponsors and Collaborators

University of Colorado, Denver
International Atomic Energy Agency
Universidad Francisco Marroquín

Investigators

Principal Investigator: Michael Hambidge, MD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT02208609

Other Study ID Numbers:

13-0282

First Posted:

Aug 5, 2014

Last Update Posted:

Apr 29, 2016

Last Verified:

Apr 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by University of Colorado, Denver

Stable isotopes of Zn

Additional relevant MeSH terms:

Malnutrition

Study Results

No Results Posted as of Apr 29, 2016