NCT06650397

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jul 2024Sep 2026

Study Start

First participant enrolled

July 31, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 21, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

October 21, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

September 4, 2024

Last Update Submit

October 18, 2024

Conditions

Zinc AbsorptionIron Absorption

Keywords

biofortificationstable isotopemaizeGuatemalaschool-aged children

Outcome Measures

Primary Outcomes (2)

  • Total absorbed iron (TAI) (mg)

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

    2 days

  • Total absorbed zinc (TAZ) (mg)

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

    1 day

Secondary Outcomes (3)

  • Plasma C-reactive protein (CRP) (mg/dL)

    1 day

  • Plasma zinc concentration (mcg/dL)

    1 day

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

    1 day

Study Arms (2)

Biofortified maize

EXPERIMENTAL

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.

Other: Biofortified maize

Traditional Maize

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Biofortified maizeOTHER

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

Biofortified maize
PlaceboOTHER

Traditional maize

Traditional Maize

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Nutrition of Central America and Panama

Guatemala City, Departamento de Guatemala, 1188, Guatemala

RECRUITING

MeSH Terms

Conditions

Callosities

Condition Hierarchy (Ancestors)

KeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nancy F Krebs, MD, MS

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Long, MS, MPH

CONTACT

303-724-5850julie.long@cuanschutz.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2024

First Posted

October 21, 2024

Study Start

July 31, 2024

Primary Completion

June 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

October 21, 2024

Record last verified: 2024-09

Locations

GU(1)