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NCT02101723 · ClinicalTrials.gov registry record · NA
Effect of Sprinkles With and w/o Fe on Zn Absorption in Kenyan Toddlers
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 63
- Enrollment target
NCT02101723 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 63 participants.
The verdict
NCT02101723, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 63 participants
- Enrollment target
Study Summary
The investigators propose to study the effects of increased iron intake by home fortification of complementary foods on the gastrointestinal microbial development, inflammatory responses, and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic area of rural Kenya who are randomized at 6 months of age to one of three fortificant groups: 1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients, including 5mg/d Zn (test); Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d Zn (control); Sprinkles™ with no micronutrients (placebo). The investigators hypothesize that the microbiome will be significantly different in the three groups and that Zn absorption and status, in addition to immune and oxidant status will be improved in the non-Fe fortified groups when compared to the Fe-fortified group.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT MNP + Zn/Fe
- DIETARY_SUPPLEMENT MNP + Zn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2011-04 |
| Est. Completion | 2016-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02101723
The ClinicalTrials.gov registry entry for NCT02101723 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02101723 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02101723 about?
NCT02101723 is a clinical study titled "Effect of Sprinkles With and w/o Fe on Zn Absorption in Kenyan Toddlers". The investigators propose to study the effects of increased iron intake by home fortification of complementary foods on the gastrointestinal microbial development, inflammatory responses, and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic area of rural Kenya...
What is the current status of trial NCT02101723?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2011-04. Estimated completion is 2016-02.
What interventions are being tested in trial NCT02101723?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), MNP + Zn/Fe (DIETARY_SUPPLEMENT), MNP + Zn (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02101723?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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