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

NCT02101723 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2018-05-21

No results posted yet for this study

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.

Conditions

  • Micronutrient Deficiencies

Interventions

DIETARY_SUPPLEMENT

MNP + Zn/Fe

Micronutrient powder with 12 mg Fe and 5 mg Zn provided daily from 6-9 months of age

DIETARY_SUPPLEMENT

MNP + Zn

Micronutrient powder with 5 mg Zn provided daily from 6-9 months of age

DIETARY_SUPPLEMENT

Placebo

Placebo powder without micronutrients

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • International Atomic Energy Agency

    collaborator OTHER_GOV

  • Moi University

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Nancy F Krebs, MD · University of Colorado, Denver

  • Fabian Esamai, MD · Moi Univeristy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
10 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-01-31
Completion
2016-02-29

Countries

  • United States
  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101723 on ClinicalTrials.gov