Effect of Iron Source on the Growth of Enteric Pathogens

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Florida State University

Status

Completed

Conditions

Iron Deficiency Anemia
Iron-deficiency
Iron Deficiency Anemia Treatment

Treatments

Dietary Supplement: Ao iron
Dietary Supplement: FeSO4

Study type

Interventional

Funder types

Other

Identifiers

NCT05314062
00002850

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

5 to 12 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

10 participants in 2 patient groups

Ferrous sulfate (FeSO4)
Active Comparator group
Description:
FeSO4 supplements containing 54 mg elemental iron
Treatment:
Dietary Supplement: FeSO4
Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)
Experimental group
Description:
Ao iron supplements containing 54 mg elemental iron
Treatment:
Dietary Supplement: Ao iron

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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