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Completed

NCT Number: NCT02208609

Zinc Bioavailability From Amaranth-enriched Maize Tortillas

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.

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Key information

Conditions

Nutritional Deficiency Callosities Keratosis Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Francisco Marroquin, Guatemala City, Guatemala

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Day 1: Maize Tortillas with 20% Amaranth

Other

Subjects received Maize tortillas with 20% Amaranth added.

Day 2 Maize Tortillas without 20% Amaranth

Other

Maize tortillas without Amaranth.

Primary outcomes

  1. Zinc Absorption

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • International Atomic Energy Agency
  • Universidad Francisco Marroquín

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 5, 2014
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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