NCT02208609

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

3.9 years

First QC Date

August 1, 2014

Last Update Submit

April 27, 2016

Conditions

Nutritional Deficiency

Keywords

Zinc AbsorptionMaizeAmaranthGuatemalaStable isotopes of Zn

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Maize Tortillas with 20% Amaranth

EXPERIMENTAL

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

Other: Day 1: Maize Tortillas with 20% Amaranth

Maize Tortillas without 20% Amaranth

EXPERIMENTAL

Children in this arm were fed maize tortillas without amaranth

Other: Day 2 Maize Tortillas without 20% Amaranth

Interventions

Day 1: Maize Tortillas with 20% AmaranthOTHER

Subjects received Maize tortillas with 20% Amaranth added.

Maize Tortillas with 20% Amaranth
Day 2 Maize Tortillas without 20% AmaranthOTHER

Maize tortillas without Amaranth.

Maize Tortillas without 20% Amaranth

Eligibility Criteria

Age18 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Universidad Francisco Marroquin

Guatemala City, Guatemala

Location

MeSH Terms

Conditions

MalnutritionCallosities

Interventions

Amaranth Dye

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Azo CompoundsOrganic ChemicalsNaphthalenesulfonatesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsPolycyclic Compounds

Study Officials

  • Michael Hambidge, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2014

First Posted

August 5, 2014

Study Start

January 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 29, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

GU(1)US(1)