Guatemala Biofortified Maize Study

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Iron Absorption; Zinc Absorption

Treatments: Other: Biofortified maize; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06650397

24-1030

7200AA23FA00027 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 10 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups, including a placebo group

Biofortified maize

Experimental group

Description:

Children consume biofortified maize that has been traditionally bred to have higher amounts of iron and zinc. Children consume the biofortified maize via 10-15 tortillas a day for 3 days.

Treatment:

Other: Biofortified maize

Traditional Maize

Placebo Comparator group

Description:

Children consume traditional maize that has lower amounts of iron and zinc compared to the biofortified maize. Children consume the maize via 10-15 tortillas a day for 3 days.

Treatment:

Other: Placebo