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| ID | Type | Description | Link |
|---|---|---|---|
| 7200AA23FA00027 | Other Grant/Funding Number | U.S. Agency for International Development | |
| 261570 | Other Grant/Funding Number | GiveWell |
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| Name | Class |
|---|---|
| Institute of Nutrition of Central America and Panama | OTHER |
| Semilla Nueva | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofortified maize | Other | Maize that has been grown to have higher amounts of iron and zinc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma C-reactive protein (CRP) (mg/dL) | CRP is used to measure systemic inflammation | 1 day |
| Plasma zinc concentration (mcg/dL) | Plasma zinc concentration is used to assess zinc status |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy F Krebs, MD, MS | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Nutrition of Central America and Panama | Guatemala City | Departamento de Guatemala | 1188 | Guatemala |
A de-identified dataset will be made available upon request.
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| ID | Term |
|---|---|
| D002145 | Callosities |
| ID | Term |
|---|---|
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo | Other | Traditional maize |
|
| 1 day |
| Plasma Alpha(1)-acid glycoprotein (AGP) (mg/dL) | AGP is used to measure systemic inflammation | 1 day |