Micronutrient Deficiencies
Conditions
Keywords
Zinc absorption, Micronutrient supplement, Microbiome, Kenya, Complementary foods, Home fortification
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).
Interventions
DIETARY_SUPPLEMENTMNP + Zn/Fe
Micronutrient powder with 12 mg Fe and 5 mg Zn provided daily from 6-9 months of age
DIETARY_SUPPLEMENTMNP + Zn
Micronutrient powder with 5 mg Zn provided daily from 6-9 months of age
DIETARY_SUPPLEMENTPlacebo
Placebo powder without micronutrients
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
International Atomic Energy Agency
Moi University
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Months to 10 Months
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
Countries
Kenya, United States
Outcome results
None listed