Guatemala Biofortified Maize Study (NCT06650397) | Clinical Trial Compass
CompletedNot Applicable
Guatemala Biofortified Maize Study
Guatemala56 participantsStarted 2024-07-31
Plain-language 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.
Who can participate
Age range
10 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.