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Completed

NCT Number: NCT02101723

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

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.

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Key information

Conditions

Micronutrient Deficiencies

Age range

5 month–10 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moi University, Eldoret, Kenya

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About this study

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:
  • Intestinal inflammation;
  • Systemic inflammation, bacterial translocation, and oxidant stress;
  • Iron status and homeostasis
  • Quantify to what degree Fe interferes with Zn absorption (TAZ) and how it affects the size of the infant's exchangeable zinc pool (EZP).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MNP + Zn/Fe

Dietary Supplement

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

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

Primary outcomes

  1. Changes in GI microbiome

    Time frame: 6 and 9 months of age

    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.

Secondary outcomes

  1. Change in Biomarkers of intestinal and system inflammation

    Time frame: 6 and 9 months of age

    Compare mean baseline and 9 month values biomarkers of intestinal and systemic inflammation and look at differences among the 3 groups.

  2. Absorption of Zn

    Time frame: 9 months of age

    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.

  3. Size of exchangeable Zn pool

    Time frame: 9 months of age

    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.

  4. Change in Biomarkers of bacterial translocation

    Time frame: 6 and 9 mo of age

    To compare biomarkers of bacterial translocation among the 3 groups and look at longitudinal differences between 6 and 9 mo of age.

  5. Change in Biomarkers of oxidative stress

    Time frame: 6 and 9 mo of age

    Compare biomarkers of oxidative stress among the 3 groups and look at longitudinal differences at 6 and 9 mo of age.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • International Atomic Energy Agency
  • Moi University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Effects of Sprinkles With and Without Iron on Zinc Absorption From Local Foods in Kenyan Toddlers, Including the Gut Microbiome

Important dates

Study start
2011
Primary completion
2013
Study completion
2016
First posted
Apr 2, 2014
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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