Guatemala Biofortified Maize Study

NCT ID: NCT06650397

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2026-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Biofortified maize

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.

Group Type: EXPERIMENTAL

Biofortified maize

Intervention Type: OTHER

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

Traditional Maize

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Traditional maize

Interventions

Biofortified maize

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

Intervention Type: OTHER

Placebo

Traditional maize

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Nutrition of Central America and Panama

OTHER

Sponsor Role: collaborator

Semilla Nueva

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy F Krebs, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Institute of Nutrition of Central America and Panama

Guatemala City, Departamento de Guatemala, Guatemala

Site Status: RECRUITING

Countries

Guatemala

Central Contacts

Julie Long, MS, MPH

Role: CONTACT

julie.long@cuanschutz.edu

303-724-5850

Facility Contacts

Manolo Mazariegos, MD

Role: primary

mmazariegos@incap.int

+502-2315-7900 ext. 1190

Manolo Mazariegos, MD

Role: backup

Other Identifiers

7200AA23FA00027

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

24-1030

Identifier Type: -

Identifier Source: org_study_id