Zinc Bioavailability From Amaranth-enriched Maize Tortillas

Nutritional Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208609
• Other study ID #: 13-0282
• Status: Completed
• Phase: N/A
• First received: August 1, 2014
• Last updated: April 27, 2016
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Nations: International Atomic Energy AgencyUnited States: Institutional Review BoardGuatemala: Comité Institucional de Ética del INCAP
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 36 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Malnutrition
• Nutritional Deficiency

Intervention

Other:
• Day 1: Maize Tortillas with 20% Amaranth
Subjects received Maize tortillas with 20% Amaranth added.
• Day 2 Maize Tortillas without 20% Amaranth
Maize tortillas without Amaranth.

Locations

Country	Name	City	State
Guatemala	Universidad Francisco Marroquin	Guatemala City
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (3)

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

Countries where clinical trial is conducted

United States,  Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Zinc Absorption	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).	2 days	No