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NCT02208609 · ClinicalTrials.gov registry record · NA
Zinc Bioavailability From Amaranth-enriched Maize Tortillas
A NA study of Nutritional Deficiency, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT02208609: Completed NA study of Nutritional Deficiency, sponsored by University of Colorado, Denver.
NCT02208609 is a NA study of Nutritional Deficiency that has completed, run by University of Colorado, Denver. The registered enrollment target is 20 participants, below the 125-participant average among 5 other Nutritional Deficiency trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02208609, a NA study of Nutritional Deficiency, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
Young children in Guatemala are at risk for nutrient deficiencies due to plant-based diets and poor sanitation. Stunting, frequent diarrhea, and respiratory infections are common. Supplementation of Zn to children during diarrhea episodes has been shown to diminish duration and severity of illness. Poor Zn absorption due to high fiber and phytate in this diet might play a role in these processes. Supplementation of this micronutrient in the diet might be beneficial. The investigators will compare absorption of Zn from white maize tortillas enriched with 20% amaranth to traditional white corn tortillas in preschool children in Guatemala.
Primary Outcome
Absorption of zinc will be compared in young children when fed the common maize tortilla and a tortilla fortified with 20 % amaranth.. Fractional absorption of zinc for a day will be measured by extrinsic labeling with stable isotopes of zinc. Fractional absorption of zinc will be measured by a dual isotope tracer ratio technique. Measurement of total zinc in duplicate diets on test day will allow determination of quantity of this micronutrient absorbed (mg/d).
Conditions Studied
Interventions
- OTHER Day 1: Maize Tortillas with 20% Amaranth
- OTHER Day 2 Maize Tortillas without 20% Amaranth
Study Locations (2)
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Other
- Universidad Francisco Marroquin - Guatemala City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-01 |
| Est. Completion | 2015-12 |
| Phase | NA |
What the finished NCT02208609 record still lists
NCT02208609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 125-participant average among 5 other Nutritional Deficiency trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Nutritional Deficiency appearing as the primary indexed condition, and to 2 interventions - of which Day 1: Maize Tortillas with 20% Amaranth is the first listed.
NCT02208609 reports a single indexed study location in Colorado, Other.
Frequently Asked Questions
What is clinical trial NCT02208609 about?
NCT02208609 is a clinical study titled "Zinc Bioavailability From Amaranth-enriched Maize Tortillas". Young children in Guatemala are at risk for nutrient deficiencies due to plant-based diets and poor sanitation. Stunting, frequent diarrhea, and respiratory infections are common. Supplementation of Zn to children during diarrhea episodes has been shown to diminish duration and severity of illness. ...
What is the current status of trial NCT02208609?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2012-01. Estimated completion is 2015-12.
What conditions does trial NCT02208609 study?
This clinical trial studies the following conditions: Nutritional Deficiency.
What interventions are being tested in trial NCT02208609?
The interventions under investigation include: Day 1: Maize Tortillas with 20% Amaranth (OTHER), Day 2 Maize Tortillas without 20% Amaranth (OTHER).
Who is sponsoring clinical trial NCT02208609?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02208609 being conducted?
This trial has 2 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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