NCT06650397

Guatemala Biofortified Maize Study

Absorption of Zinc and Iron from Nixtamalized Biofortified Maize in School-aged Children in Guatemala

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 10 Years – 14 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
OTHER	Biofortified maize	Maize that has been grown to have higher amounts of iron and zinc.
OTHER	Placebo	Traditional maize

Timeline

• Start date: 2024-07-31
• Primary completion: 2025-06-01
• Completion: 2026-09-01
• First posted: 2024-10-21
• Last updated: 2024-10-21

Locations

1 site across 1 country: Guatemala