Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650397
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
Guatemala Biofortified Maize Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Absorption of Zinc and Iron from Nixtamalized Biofortified Maize in School-aged Children in Guatemala
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 28group 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None