Iron Absorption, Zinc Absorption
Conditions
Keywords
biofortification, stable isotope, maize, Guatemala, school-aged children
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.
Interventions
OTHERPlacebo
Traditional maize
OTHERBiofortified maize
Maize that has been grown to have higher amounts of iron and zinc.
Sponsors
University of Colorado, Denver
Institute of Nutrition of Central America and Panama
Semilla Nueva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 14 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total absorbed iron (TAI) (mg) | 2 days | Total absorbed iron from the diet = fractional absorption of iron x total dietary iron (mg) |
| Total absorbed zinc (TAZ) (mg) | 1 day | Total zinc absorbed from the diet = fractional absorption of zinc x total dietary zinc (mg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma C-reactive protein (CRP) (mg/dL) | 1 day | CRP is used to measure systemic inflammation |
| Plasma zinc concentration (mcg/dL) | 1 day | Plasma zinc concentration is used to assess zinc status |
| Plasma Alpha(1)-acid glycoprotein (AGP) (mg/dL) | 1 day | AGP is used to measure systemic inflammation |
Countries
Guatemala
Contacts
PRINCIPAL_INVESTIGATORNancy F Krebs, MD, MS
University of Colorado, Denver
Outcome results
None listed