NCT02101723

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

1.8 years

First QC Date

March 28, 2014

Last Update Submit

May 18, 2018

Conditions

Micronutrient Deficiencies

Keywords

Zinc absorptionMicronutrient supplementMicrobiomeKenyaComplementary foodsHome fortification

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in Biomarkers of intestinal and system inflammation

    6 and 9 months of age

  • Absorption of Zn

    9 months of age

  • Size of exchangeable Zn pool

    9 months of age

  • Change in Biomarkers of bacterial translocation

    6 and 9 mo of age

  • Change in Biomarkers of oxidative stress

    6 and 9 mo of age

Study Arms (3)

Micronutrient Powder (MNP) + Zn/Fe

ACTIVE COMPARATOR

Micronutrient Powder with 5 mg Zn and 12 mg Fe

Dietary Supplement: MNP + Zn/Fe

MNP + Zn

ACTIVE COMPARATOR

Micronutrient Powder with 5 mg Zn

Dietary Supplement: MNP + Zn

Control

PLACEBO COMPARATOR

Placebo sachets without micronutrients

Dietary Supplement: Placebo

Interventions

MNP + Zn/FeDIETARY_SUPPLEMENT

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

Micronutrient Powder (MNP) + Zn/Fe
MNP + ZnDIETARY_SUPPLEMENT

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

MNP + Zn
PlaceboDIETARY_SUPPLEMENT

Placebo powder without micronutrients

Control

Eligibility Criteria

Age5 Months - 10 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Moi University

Eldoret, Kenya

Location

Related 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. doi: 10.3390/nu6125636.

    PMID: 25493942BACKGROUND

Study Officials

  • Nancy F Krebs, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

  • Fabian Esamai, MD

    Moi Univeristy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2014

First Posted

April 2, 2014

Study Start

April 1, 2011

Primary Completion

January 1, 2013

Study Completion

February 1, 2016

Last Updated

May 21, 2018

Record last verified: 2018-05

Locations

US(1)KE(1)