Clinical trial NCT02101723: Effect of Sprinkles With and w/o Fe on Zn Absorption in Kenyan Toddlers
Official title: Effects of Sprinkles With and Without Iron on Zinc Absorption From Local Foods in Kenyan Toddlers, Including the Gut Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Micronutrient Deficiencies
Keywords: Zinc absorption
Micronutrient supplement
Microbiome
Kenya
Complementary foods
Home fortification
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: International Atomic Energy Agency
name: Moi University
First posted: 2014-04-02
Enrollment: 63
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes in GI microbiome
timeFrame: 6 and 9 months of age
Secondary outcomes:
measure: Change in Biomarkers of intestinal and system inflammation
timeFrame: 6 and 9 months of age
measure: Absorption of Zn
timeFrame: 9 months of age
measure: Size of exchangeable Zn pool
timeFrame: 9 months of age
measure: Change in Biomarkers of bacterial translocation
timeFrame: 6 and 9 mo of age
measure: Change in Biomarkers of oxidative stress
timeFrame: 6 and 9 mo of age
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Eldoret
country: Kenya
facility: Moi University
Study officials:
affiliation: University of Colorado, Denver
name: Nancy F Krebs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moi Univeristy
name: Fabian Esamai, MD
role: STUDY_DIRECTOR
References:
citation: Esamai F, Liechty E, Ikemeri J, Westcott J, Kemp J, Culbertson D, Miller LV, Hambidge KM, Krebs NF. Zinc absorption from micronutrient powder is low but is not affected by iron in Kenyan infants. Nutrients. 2014 Dec;6(12):5636-51. doi: 10.3390/nu6125636.