Overview

This trial is active, not recruiting.

Condition micronutrient deficiencies
Treatments mnp + zn/fe, mnp + zn, placebo
Sponsor University of Colorado, Denver
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date April 2011
End date January 2013
Trial size 63 participants
Trial identifier NCT02101723, 11-0227, 15827, 16933, K24DK083772

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Micronutrient Powder with 5 mg Zn and 12 mg Fe
mnp + zn/fe
Micronutrient powder with 12 mg Fe and 5 mg Zn provided daily from 6-9 months of age
(Active Comparator)
Micronutrient Powder with 5 mg Zn
mnp + zn
Micronutrient powder with 5 mg Zn provided daily from 6-9 months of age
(Placebo Comparator)
Placebo sachets without micronutrients
placebo
Placebo powder without micronutrients

Primary Outcomes

Measure
Changes in GI microbiome
time frame: 6 and 9 months of age

Secondary Outcomes

Measure
Change in Biomarkers of intestinal and system inflammation
time frame: 6 and 9 months of age
Absorption of Zn
time frame: 9 months of age
Size of exchangeable Zn pool
time frame: 9 months of age
Change in Biomarkers of bacterial translocation
time frame: 6 and 9 mo of age
Change in Biomarkers of oxidative stress
time frame: 6 and 9 mo of age

Eligibility Criteria

Male or female participants from 5 months up to 10 months old.

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

Additional Information

Official title Effects of Sprinkles With and Without Iron on Zinc Absorption From Local Foods in Kenyan Toddlers, Including the Gut Microbiome
Principal investigator Nancy F Krebs, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.