Micronutrient Deficiencies Clinical Trial
Official title:
Effects of Sprinkles With and Without Iron on Zinc Absorption From Local Foods in Kenyan Toddlers, Including the Gut Microbiome
Verified date | May 2018 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 63 |
Est. completion date | February 2016 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Months to 10 Months |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Kenya | Moi University | Eldoret | |
United States | University of Colorado Denver | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | International Atomic Energy Agency, Moi University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States, Kenya,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in GI microbiome | 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. | 6 and 9 months of age | |
Secondary | Change in Biomarkers of intestinal and system inflammation | Compare mean baseline and 9 month values biomarkers of intestinal and systemic inflammation and look at differences among the 3 groups. | 6 and 9 months of age | |
Secondary | Absorption of Zn | 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. | 9 months of age | |
Secondary | Size of exchangeable Zn pool | 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. | 9 months of age | |
Secondary | Change in Biomarkers of bacterial translocation | To compare biomarkers of bacterial translocation among the 3 groups and look at longitudinal differences between 6 and 9 mo of age. | 6 and 9 mo of age | |
Secondary | Change in Biomarkers of oxidative stress | Compare biomarkers of oxidative stress among the 3 groups and look at longitudinal differences at 6 and 9 mo of age. | 6 and 9 mo of age |
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