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Search / Trial NCT06650397

Guatemala Biofortified Maize Study

Launched by UNIVERSITY OF COLORADO, DENVER · Oct 18, 2024

Trial Information

Current as of November 05, 2025

Recruiting

Keywords

Biofortification Stable Isotope Maize Guatemala School Aged Children

ClinConnect Summary

The Guatemala Biofortified Maize Study is looking at how a special type of corn, called biofortified maize, can help improve the absorption of important nutrients like zinc and iron in school-aged children. Zinc and iron deficiencies are common in Guatemala, and this study aims to see if eating tortillas made from this biofortified maize can provide more of these nutrients compared to regular maize tortillas. The study will involve 56 children, aged 10 to 14 years, who will be randomly assigned to eat either the biofortified maize or the regular maize for 27 days. Researchers will take measurements and collect samples to see how much zinc and iron the children absorb from their diet.

To participate, children must be between 10 and 14 years old, eat homemade tortillas daily, and have a body mass index (BMI) within a certain range. However, those taking iron or zinc supplements, or who have low hemoglobin levels (which can indicate anemia), won't be eligible. During the study, participants will have their growth measured and provide blood, stool, and urine samples to help researchers understand how well they are absorbing these vital nutrients. This study is an important step in improving nutrition among children in agricultural communities in Guatemala.

Gender

ALL

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

About University Of Colorado, Denver

The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.

Locations

Guatemala City, Guatemala

Patients applied

0 patients applied

Trial Officials

Nancy F Krebs, MD, MS

Principal Investigator

University of Colorado, Denver

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported