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

Not Applicable

Completed

Interventions: Dietary Supplement: MNP + Zn
Dietary Supplement: MNP + Zn/Fe
Dietary Supplement: Placebo

Brief 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).

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
MNP + Zn	MNP + Zn	Micronutrient Powder with 5 mg Zn
Micronutrient Powder (MNP) + Zn/Fe	MNP + Zn/Fe	Micronutrient Powder with 5 mg Zn and 12 mg Fe
Control	Placebo	Placebo sachets without micronutrients

Primary Outcome Measures

Name	Time	Method
Changes in GI microbiome	6 and 9 months of age	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.

Secondary Outcome Measures

Name	Time	Method
Absorption of Zn	9 months of age	Determine the effects of increased iron intake on zinc absorption from micronutrient powder added to local complementary foods of Kenyan toddlers in a malaria-endemic area.
Size of exchangeable Zn pool	9 months of age	Determine the effect of increase iron intake on size of exchangeable Zn pool (EZP) after 3 months of home fortification with micronutrient powder in maize-based diets in rural Kenyan infants.
Change in Biomarkers of bacterial translocation	6 and 9 mo of age	To compare biomarkers of bacterial translocation among the 3 groups and look at longitudinal differences between 6 and 9 mo of age.
Change in Biomarkers of intestinal and system inflammation	6 and 9 months of age	Compare mean baseline and 9 month values biomarkers of intestinal and systemic inflammation and look at differences among the 3 groups.
Change in Biomarkers of oxidative stress	6 and 9 mo of age	Compare biomarkers of oxidative stress among the 3 groups and look at longitudinal differences at 6 and 9 mo of age.

Locations (2): University of Colorado Denver
🇺🇸
Aurora, Colorado, United States
Moi University
🇰🇪
Eldoret, Kenya