Using biofortified maize to improve zinc and iron absorption in children
Absorption of Zinc and Iron from Nixtamalized Biofortified Maize in School-aged Children in Guatemala
This study is testing if a special type of corn can help school-aged children in Guatemala absorb more zinc and iron from their food compared to regular corn.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 10 Years to 14 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Guatemala City) |
| Trial ID | NCT06650397 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of nixtamalized biofortified maize in increasing dietary zinc and iron intake among school-aged children in Guatemala. It is a randomized, double-blinded comparison involving two groups: one consuming biofortified maize and the other consuming traditional maize. Over a period of 27 days, participants will undergo various measurements, including blood, stool, and urine samples, to assess the absorption of these essential nutrients. The study will enroll up to 56 children aged 10-14 years from agricultural communities in the Western Highlands.
Who should consider this trial
Good fit: Ideal candidates for this study are school-aged children between 10-14 years old who regularly consume homemade tortillas.
Not a fit: Patients currently taking iron or zinc supplements or those with low hemoglobin levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the nutritional status of children in Guatemala by enhancing their zinc and iron absorption.
How similar studies have performed: Other studies on biofortification have shown promise in improving nutrient absorption, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guatemala City
- Institute of Nutrition of Central America and Panama — Guatemala City, Guatemala (Recruiting)
Study contacts
- Principal investigator: Nancy F Krebs, MD, MS — University of Colorado, Denver
- Study coordinator: Julie Long, MS, MPH
- Email: julie.long@cuanschutz.edu
- Phone: 303-724-5850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.