Iron-deficiencyNCT05314062
Effect of Iron Source on the Growth of Enteric Pathogens
A study testing FeSO4 and Ao iron in people with Iron-deficiency and Iron Deficiency Anemia, run by Florida State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment
- What is being tested?
- FeSO4 and Ao iron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2022to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children 5-12 y
- Willing to donate stool sample
Who cannot join
- Currently taking antibiotics
- Currently taking a vitamin and mineral supplement containing iron
- Wards of the state, including children in foster care
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Effect of Iron-enriched Aspergillus Oryzae Compared to Ferrous Sulfate on the Growth and Virulence of Common 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 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.
- Being tested
- FeSO4, Ao iron
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeSO4Dietary supplement
2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)
Ao ironDietary supplement
2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron)
| Study group | Role | What they receive |
|---|---|---|
| Ferrous sulfate (FeSO4) | Active comparator | FeSO4 supplements containing 54 mg elemental iron Receives: Dietary Supplement: FeSO4 |
| Ferrous sulfate-enriched Aspergillus oryzae (Ao iron) | Experimental | Ao iron supplements containing 54 mg elemental iron Receives: Dietary Supplement: Ao iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of iron taken up by enteric pathogens
Iron uptake of common enteric pathogens will be determined in stool following in vitro fecal fermentation.
Measured: 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.
Measured: 0-24 hours
Secondary outcomes (2)
Gut microbiome composition and diversity
Gut microbiome composition will be determined in stool following in vitro fecal fermentation using 16S rRNA gene sequencing.
Measured: 0-24 hours
Individual fecal short chain fatty acid (SCFA) concentration
Individual SCFAs will be determined in stool following in vitro fecal fermentation by liquid chromatography-mass spectrometry.
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start18 Mar 2022
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen R. Hennigar, Ph.D., Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314062
- Sponsor's protocol ID
- 00002850
- Status last verified
- Jun 2022
- First submitted
- 19 Mar 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Iron-enriched Aspergillus Oryzae Compared to Ferrous Sulfate on the Growth and Virulence of Common Enteric Pathogens
- ClinicalTrials.gov ID
- NCT05314062
- Acronym / sponsor ID
- 00002850
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrous sulfate (FeSO4) | Active comparator | Dietary Supplement: FeSO4FeSO4 supplements containing 54 mg elemental iron |
| Ferrous sulfate-enriched Aspergillus oryzae (Ao iron) | Experimental | Dietary Supplement: Ao ironAo iron supplements containing 54 mg elemental iron |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy children 5-12 y
- Willing to donate stool sample
Key exclusion criteria (3 listed)
- Currently taking antibiotics
- Currently taking a vitamin and mineral supplement containing iron
- Wards of the state, including children in foster care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FeSO42 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron) | Dietary supplement | Ferrous sulfate (FeSO4) |
| Ao iron2 Ao iron supplements containing 27 mg elemental iron/supplements (54 mg total iron) | Dietary supplement | Ferrous sulfate-enriched Aspergillus oryzae (Ao iron) |
Primary outcome
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.
2 secondary outcomes
Gut microbiome composition and diversity
Time frame: 0-24 hours
Individual fecal short chain fatty acid (SCFA) concentration
Time frame: 0-24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FeSO4 and Ao iron in people with Iron-deficiency and Iron Deficiency Anemia, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of iron taken up by enteric pathogens (time frame: 0-24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.