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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: Completed NA study, sponsored by University of Colorado, Denver.
NCT02101723 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 63 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Identify and quantify the phylogenic distribution of bacterial genera in the infants from 6 to 9 months in prevalence or abundance with iron supplementation at baseline, mid-point and 9 months.
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 |
What the finished NCT02101723 record still lists
NCT02101723 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02101723 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02101723's enrollment target sits among peer trials
63 1157th of 2000 higher than 844 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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