Iron-deficiency, Iron Deficiency Anaemia Due to Dietary Causes, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFerrous sulfate
2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)
DIETARY_SUPPLEMENTFerrous sulfate-enriched Aspergillus oryzae (Ao iron)
2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)
Sponsors
Iowa State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
This is a double-blind study
Intervention model description
Dietary Supplement: FeSO4 Dietary Supplement: Ao iron
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of iron taken up by enteric pathogens | Time Frame: 0-24 hours | Iron uptake of common enteric pathogens will be determined in stool following in vitro fecal fermentation. |
| Growth of enteric pathogens measured by optical density | Time Frame: 0-24 hours | Growth of common enteric pathogens will be determined in stool following in vitro fecal fermentation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiome composition and diversity | Time Frame: 0-24 hours | Gut microbiome composition will be determined in stool following in vitro fecal fermentation using 16S rRNA gene sequencing. |
| Individual fecal short chain fatty acid (SCFA) concentration | Time Frame: 0-24 hours | Individual SCFAs will be determined in stool following in vitro fecal fermentation by liquid chromatography-mass spectrometry. |
Countries
United States
Outcome results
None listed