Effect of Iron Source on the Growth of Enteric Pathogens

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-18

Study Completion Date

2022-06-20

Brief Summary

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The World Health Organization recommends daily iron supplementation for infants and children (6 months-12 years). Based on the low cost and high bioavailability and efficacy, ferrous sulfate is typically the first choice for supplementation and fortification. The recommended dose of iron is set high to deliver adequate absorbed iron due to low rates of dietary iron absorption, which is typically \<10%. Thus, the majority of dietary iron is not absorbed and travels to the colon. Unabsorbed iron in the colon may select for enteric pathogens at the expense of beneficial commensal bacteria and increase infection risk, including the clinical incidence of diarrhea. The objective of this study is to compare the effects of iron as ferrous sulfate (FeSO4) or FeSO4-enriched Aspergillus oryzae (Ao iron) on the growth and virulence of common enteric pathogens using an in vitro fecal fermentation model. Stool samples will be collected from children following ingestion of an iron supplement as either FeSO4 or Ao iron. Stool samples will be spiked with common enteric pathogens and outcome measures will be determined following in vitro fecal fermentation.

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Detailed Description

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Conditions

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Iron-deficiency Iron Deficiency Anemia Iron Deficiency Anemia Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

This is a double-blind study

Study Groups

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Ferrous sulfate (FeSO4)

FeSO4 supplements containing 54 mg elemental iron

Group Type ACTIVE_COMPARATOR

FeSO4

Intervention Type DIETARY_SUPPLEMENT

2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)

Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)

Ao iron supplements containing 54 mg elemental iron

Group Type EXPERIMENTAL

Ao iron

Intervention Type DIETARY_SUPPLEMENT

2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)

Interventions

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FeSO4

2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)

Intervention Type DIETARY_SUPPLEMENT

Ao iron

2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy children 5-12 y
* Willing to donate stool sample

Exclusion Criteria

* Currently taking antibiotics
* Currently taking a vitamin and mineral supplement containing iron
* Wards of the state, including children in foster care

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes