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Guatemala Biofortified Maize Study

NCT06650397 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-05-08

No results posted yet for this study

Summary

Zinc (Zn) and iron (Fe) deficiencies are common in Guatemala, and maize is a staple food throughout the country. The primary aim of this study is to demonstrate if utilizing nixtamalized biofortified maize has the potential to increase dietary Zn and Fe intake and improve the amount of Zn and Fe absorbed when compared to diets incorporating traditional maize (control). This is a randomized, double blinded, comparison study of biofortified vs control maize prepared as tortillas from nixtamalized masa. This study will enroll up to 56 school aged children (10-14 yrs old) living in agricultural communities in the Western Highlands of Guatemala (28/group x 2 groups). Researchers will utilize Zn and Fe stable isotopes to measure total absorbed Zn and Fe. Participants will be active in the study for 27 days. During this time, they will have anthropometric measurements taken and collect 2 blood samples, 1 stool sample, and 9 urine samples.

Conditions

  • Zinc Absorption
  • Iron Absorption

Interventions

OTHER

Biofortified maize

Maize that has been grown to have higher amounts of iron and zinc.

OTHER

Placebo

Traditional maize

Sponsors & Collaborators

  • Institute of Nutrition of Central America and Panama

    collaborator OTHER

  • Semilla Nueva

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Nancy F Krebs, MD, MS · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • Guatemala

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06650397 on ClinicalTrials.gov