Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTFeSO4
2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)
DIETARY_SUPPLEMENTAo iron
2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)
Sponsors
Florida 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
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of iron taken up by enteric pathogens | 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 | 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 | 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 | 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