Effect of Sprinkles With and w/o Fe on Zn Absorption in Kenyan Toddlers

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101723
• Other study ID #: 11-0227
• Secondary ID: K24DK08377215827
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: February 2016

Study information

• Verified date: May 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Micronutrient Deficiencies

Intervention

Dietary Supplement:
• MNP + Zn/Fe
Micronutrient powder with 12 mg Fe and 5 mg Zn provided daily from 6-9 months of age
• MNP + Zn
Micronutrient powder with 5 mg Zn provided daily from 6-9 months of age
• Placebo
Placebo powder without micronutrients

Locations

Country	Name	City	State
Kenya	Moi University	Eldoret
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	International Atomic Energy Agency, Moi University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Countries where clinical trial is conducted

United States,  Kenya, 

References & Publications (1)

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

Outcome

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