- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02101723
Effect of Sprinkles With and w/o Fe on Zn Absorption in Kenyan Toddlers
Effects of Sprinkles With and Without Iron on Zinc Absorption From Local Foods in Kenyan Toddlers, Including the Gut Microbiome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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:
- 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Eldoret, Kenya
- Moi University
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-
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Denver
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Micronutrient Powder (MNP) + Zn/Fe
Micronutrient Powder with 5 mg Zn and 12 mg Fe
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Micronutrient powder with 12 mg Fe and 5 mg Zn provided daily from 6-9 months of age
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Active Comparator: MNP + Zn
Micronutrient Powder with 5 mg Zn
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Micronutrient powder with 5 mg Zn provided daily from 6-9 months of age
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Placebo Comparator: Control
Placebo sachets without micronutrients
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Placebo powder without micronutrients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in GI microbiome
Time Frame: 6 and 9 months of age
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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.
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6 and 9 months of age
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Biomarkers of intestinal and system inflammation
Time Frame: 6 and 9 months of age
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Compare mean baseline and 9 month values biomarkers of intestinal and systemic inflammation and look at differences among the 3 groups.
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6 and 9 months of age
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Absorption of Zn
Time Frame: 9 months of age
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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.
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9 months of age
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Size of exchangeable Zn pool
Time Frame: 9 months of age
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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.
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9 months of age
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Change in Biomarkers of bacterial translocation
Time Frame: 6 and 9 mo of age
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To compare biomarkers of bacterial translocation among the 3 groups and look at longitudinal differences between 6 and 9 mo of age.
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6 and 9 mo of age
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Change in Biomarkers of oxidative stress
Time Frame: 6 and 9 mo of age
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Compare biomarkers of oxidative stress among the 3 groups and look at longitudinal differences at 6 and 9 mo of age.
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6 and 9 mo of age
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nancy F Krebs, MD, University of Colorado, Denver
- Study Director: Fabian Esamai, MD, Moi Univeristy
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 11-0227
- 16933 (Other Grant/Funding Number: IAEA)
- K24DK083772 (U.S. NIH Grant/Contract)
- 15827 (Other Grant/Funding Number: IAEA)
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