Effect of Iron Supplements on the Growth of Enteric Pathogens

NCT05762380 | Completed

• 1 other identifier: IVFE
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Concentration of iron taken up by enteric pathogens

  Iron uptake of common enteric pathogens will be determined in stool following in vitro fecal fermentation.

  Time Frame: 0-24 hours

• Growth of enteric pathogens measured by optical density

  Growth of common enteric pathogens will be determined in stool following in vitro fecal fermentation.

  Time Frame: 0-24 hours

Secondary Outcomes (2)

• Gut microbiome composition and diversity

  Time Frame: 0-24 hours

• Individual fecal short chain fatty acid (SCFA) concentration

  Time Frame: 0-24 hours

Study Arms (2)

Ferrous sulfate (FeSO4)

ACTIVE COMPARATOR

FeSO4 supplements containing 54 mg elemental iron

Dietary Supplement: Ferrous sulfate

Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)

EXPERIMENTAL

Ao iron supplements containing 54 mg elemental iron

Dietary Supplement: Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)

Interventions

Ferrous sulfate DIETARY_SUPPLEMENT

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

Ferrous sulfate (FeSO4)

Ferrous sulfate-enriched Aspergillus oryzae (Ao iron) DIETARY_SUPPLEMENT

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

Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: Self-representation of gender identity at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iowa State University: lead

Study Sites (1)

Iowa State University

Ames, Iowa, 50011, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Manju B Reddy, Ph.D.

  Iowa State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doris A. Adams Endowed Chair

Model Details: Dietary Supplement: FeSO4 Dietary Supplement: Ao iron

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 9, 2023
• Study Start: June 14, 2022
• Primary Completion: August 2, 2022
• Study Completion: August 2, 2022
• Last Updated: March 9, 2023

Record last verified: 2022-09

Locations

US (1)