Effect of Iron Supplements 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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-14

Study Completion Date

2022-08-02

Brief Summary

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Iron supplementation is a common approach to address iron deficiency with recommendations for women of childbearing age, particularly those at risk of iron deficiency. Because of its considerably higher absorption, ferrous sulphate is the common iron compound used in iron supplements. However, concerns about iron supplements arise from the knowledge that a large portion of the supplement consumed is not absorbed. This unabsorbed iron travels to the colon and, in preclinical studies, has been shown to promote the growth of 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 women of reproductive age 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 Anaemia Due to Dietary Causes Iron Deficiency Anemia Treatment Iron Deficiency Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Dietary Supplement: FeSO4 Dietary Supplement: Ao iron

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

Ferrous sulfate

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

Ferrous sulfate-enriched Aspergillus oryzae (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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Ferrous sulfate

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

Intervention Type DIETARY_SUPPLEMENT

Ferrous sulfate-enriched Aspergillus oryzae (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

* Women 18-44 y
* Are able to swallow the iron pills provided for the study
* BMI 18.5 to 29.9 kg/m2
* Willing to provide blood samples
* Willing to collect stool samples

Exclusion Criteria

* Currently taking any antibiotics
* Iron overload condition/hemochromatosis
* History of chronic gastrointestinal disorders/diseases
* Currently smoke cigarettes (including vaping)
* Have donated blood recently (in the last two weeks)
* Currently taking a vitamin and mineral supplement containing iron
* Pregnant and lactating/breastfeeding women
* Allergic to any of the ingredients (wheat, egg, butter, milk, and baking powder, blue dye) in the muffins

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes