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NCT05314062 · ClinicalTrials.gov registry record · NA
Effect of Iron Source on the Growth of Enteric Pathogens
A NA study, sponsored by Florida State University.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT05314062 is a NA study that has completed, run by Florida State University. The registered enrollment target is 10 participants.
The verdict
NCT05314062, a NA study, has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study 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_SUPPLEMENT FeSO4
- DIETARY_SUPPLEMENT Ao iron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-03-18 |
| Est. Completion | 2022-06-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05314062
The ClinicalTrials.gov registry entry for NCT05314062 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida State University, which has 219 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which FeSO4 is the first listed.
NCT05314062 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05314062 about?
NCT05314062 is a clinical study titled "Effect of Iron Source on the Growth of Enteric Pathogens". 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...
What is the current status of trial NCT05314062?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2022-03-18. Estimated completion is 2022-06-20.
What interventions are being tested in trial NCT05314062?
The interventions under investigation include: FeSO4 (DIETARY_SUPPLEMENT), Ao iron (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05314062?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
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