NCT02101723

Effect of Sprinkles With and w/o Fe on Zn Absorption in Kenyan Toddlers

Effects of Sprinkles With and Without Iron on Zinc Absorption From Local Foods in Kenyan Toddlers, Including the Gut Microbiome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 5 Months – 10 Months
• Healthy volunteers: Accepted

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.

Detailed description

Specific aims include exploration of possible mechanisms of adverse events that have been observed in iron supplementation trials in infants in malaria endemic regions by: 1. Characterizing the impact of enteral iron administration on the evolution of the intestinal microbiome in infants from 6 to 9 months of age. 2. Characterizing iron administration-associated inflammatory responses and correlate these with changes in the intestinal microbiome in infants from 6 to 9 months of age. Specifically, changes in the microbiome will be correlated with biomarkers reflecting: 1. Intestinal inflammation; 2. Systemic inflammation, bacterial translocation, and oxidant stress; 3. Iron status and homeostasis 3. Quantify to what degree Fe interferes with Zn absorption (TAZ) and how it affects the size of the infant's exchangeable zinc pool (EZP).

Conditions

• Micronutrient Deficiencies

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MNP + Zn/Fe	Micronutrient powder with 12 mg Fe and 5 mg Zn provided daily from 6-9 months of age
DIETARY_SUPPLEMENT	MNP + Zn	Micronutrient powder with 5 mg Zn provided daily from 6-9 months of age
DIETARY_SUPPLEMENT	Placebo	Placebo powder without micronutrients

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-01-01
• Completion: 2016-02-01
• First posted: 2014-04-02
• Last updated: 2018-05-21

Locations

2 sites across 2 countries: United States, Kenya