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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: Completed NA study, sponsored by Florida State University.
NCT05314062 is a NA study that has completed, run by Florida State University. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Iron uptake of common enteric pathogens will be determined in stool 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 |
What the finished NCT05314062 record still lists
NCT05314062 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which FeSO4 is the first listed.
NCT05314062 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05314062's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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