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Effect of Iron Supplements on the Growth of Enteric Pathogens

NCT05762380 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-03-09

No results posted yet for this study

Summary

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.

Conditions

  • Iron-deficiency
  • Iron Deficiency Anaemia Due to Dietary Causes
  • Iron Deficiency Anemia Treatment
  • Iron Deficiency Anemia

Interventions

DIETARY_SUPPLEMENT

Ferrous sulfate

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

DIETARY_SUPPLEMENT

Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)

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

Sponsors & Collaborators

  • Iowa State University

    lead OTHER

Principal Investigators

  • Manju B Reddy, Ph.D. · Iowa State University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2022-08-02
Completion
2022-08-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05762380 on ClinicalTrials.gov