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| ID | Type | Description | Link |
|---|---|---|---|
| K24DK083772 | U.S. NIH Grant/Contract | View source | |
| 15827 | Other Grant/Funding Number | IAEA | |
| 16933 | Other Grant/Funding Number | IAEA |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| International Atomic Energy Agency | OTHER_GOV |
| Moi University | OTHER |
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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.
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:
Characterizing the impact of enteral iron administration on the evolution of the intestinal microbiome in infants from 6 to 9 months of age.
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:
Quantify to what degree Fe interferes with Zn absorption (TAZ) and how it affects the size of the infant's exchangeable zinc pool (EZP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micronutrient Powder (MNP) + Zn/Fe | Active Comparator | Micronutrient Powder with 5 mg Zn and 12 mg Fe |
|
| MNP + Zn | Active Comparator | Micronutrient Powder with 5 mg Zn |
|
| Control | Placebo Comparator | Placebo sachets without micronutrients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MNP + Zn/Fe | Dietary Supplement | Micronutrient powder with 12 mg Fe and 5 mg Zn provided daily from 6-9 months of age |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Absorption of Zn |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy F Krebs, MD | University of Colorado, Denver | Principal Investigator |
| Fabian Esamai, MD | Moi Univeristy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States | ||
| Moi University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25493942 | Background | 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. |
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| MNP + Zn | Dietary Supplement | Micronutrient powder with 5 mg Zn provided daily from 6-9 months of age |
|
| Placebo | Dietary Supplement | Placebo powder without micronutrients |
|
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 |
| 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 |
| 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 |
| 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 |
| Eldoret |
| Kenya |