Effect of Sprinkles With and w/o Fe on Zn Absorption in Kenyan Toddlers
Completed · Not applicable · Has a placebo group
Conditions studied: Micronutrient Deficiencies
In brief
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.
Key facts
- Study ID
- NCT02101723
- Run by
- University of Colorado, Denver
- People needed
- 63
- Starts
- 2011-04-01
- Expected to finish
- 2016-02-01
- Last updated by the study team
- 2018-05-21
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Term infant
- Birthweight > 2500 g
- Healthy with no apparent congenital anomalies
- Up-to-date with vaccinations
- Hb >10 g/dL
- Breastfeeding with intent to continue for duration of study
- Negative blood slide for malaria
- Written informed consent
You may not qualify if…
- Acute malnutrition
- Current or anticipated used of infant formula or other fortified products
- Current or planned use of iron (or zinc) supplements
- Previous hospitalization for malaria within the last four weeks
- Persistent diarrhea
Where it is running
- University of Colorado Denver — Aurora, Colorado, United States
- Moi University — Eldoret, Kenya
Full record on ClinicalTrials.gov
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