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Completed

NCT Number: NCT06650397

Guatemala Biofortified Maize Study

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.

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Key information

Conditions

Zinc Absorption Callosities Iron Absorption Keratosis Skin Diseases Skin and Connective Tissue Diseases

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Nutrition of Central America and Panama

Guatemala City, Departamento de Guatemala, 1188, Guatemala

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 10-14 years old school children (male and female sex)
  • BMI between10-85%tile
  • Typically eat homemade tortillas at each meal every day

Exclusion criteria

  • Taking iron or zinc supplements
  • Hemoglobin less than 12.9 g/dl for children 10-11 yrs old and less than13.4 g/dl for children 12-14 yrs old (Per the WHO's 2024 publication hemoglobin cut-offs for identifying anemia are 5-11 yrs: less than 11.5 g/dl; 12-14 yrs: less than 12.0 g/dl. To adjust for the elevation of Tecpán at 2254 m, 1.4 g/dl is added to the cut-off point.)
  • Girls who are having a menstrual period during the metabolic studies

Treatment and study plan

Biofortified maize

Other

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

Placebo

Other

Traditional maize

Primary outcomes

  1. Total absorbed iron (TAI) (mg)

    Time frame: 2 days

    Total absorbed iron from the diet = fractional absorption of iron x total dietary iron (mg)

  2. Total absorbed zinc (TAZ) (mg)

    Time frame: 1 day

    Total zinc absorbed from the diet = fractional absorption of zinc x total dietary zinc (mg)

Secondary outcomes

  1. Plasma C-reactive protein (CRP) (mg/dL)

    Time frame: 1 day

    CRP is used to measure systemic inflammation

  2. Plasma zinc concentration (mcg/dL)

    Time frame: 1 day

    Plasma zinc concentration is used to assess zinc status

  3. Plasma Alpha(1)-acid glycoprotein (AGP) (mg/dL)

    Time frame: 1 day

    AGP is used to measure systemic inflammation

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Institute of Nutrition of Central America and Panama
  • Semilla Nueva

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2024
Registry last updated
May 8, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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