Zinc Bioavailability From Amaranth-enriched Maize Tortillas

• Register: ClinicalTrials.gov
• Last refreshed on: 9 May 2016
• Main ID: NCT02208609
• Date of registration: 01/08/2014
• Prospective Registration: No
• Primary sponsor: University of Colorado, Denver
• Public title: Zinc Bioavailability From Amaranth-enriched Maize Tortillas
• Scientific title: Absorption of Zinc (Zn) From Traditional Maize Tortillas and Amaranth-enriched Tortillas by Toddlers in the Indigenous Post-Mayan Population
• Date of first enrolment: January 2012
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02208609
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)
• Phase: N/A

Countries of recruitment

Guatemala, United States

Contacts

• Name: Michael Hambidge, MD
• Affiliation: University of Colorado, Denver

Key inclusion & exclusion criteria

Inclusion Criteria:

- 2-3 years of age

- apparently healthy

- eats >2-3 tortillas at each meal of the day.

Exclusion Criteria:

- Chispitas or macrovital supplementation

- breastfeeding

- birth weight < 2,500 g

- birth defect affecting growth and development

- chronic infection

- twin or triplet

- sibling enrolled in study



Age minimum: 18 Months
Age maximum: 36 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Nutritional Deficiency

Intervention(s)

Other: Day 1: Maize Tortillas with 20% Amaranth

Other: Day 2 Maize Tortillas without 20% Amaranth

Primary Outcome(s)

Zinc Absorption [Time Frame: 2 days]

Secondary ID(s)

13-0282

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Universidad Francisco Marroquín

International Atomic Energy Agency