Iron-deficiencyNCT05762380
Effect of Iron Supplements on the Growth of Enteric Pathogens
A study testing Ferrous sulfate and Ferrous sulfate-enriched Aspergillus oryzae (Ao iron) in people with Iron-deficiency and Iron Deficiency Anaemia Due to Dietary Causes, run by Iowa State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Iron Deficiency Anaemia Due to Dietary Causes, Iron Deficiency Anemia Treatment
- What is being tested?
- Ferrous sulfate and Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2022to 2 Aug 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 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vitro Fecal Fermentation Following Ingestion of Iron-enriched Aspergillus Oryzae or Iron Sulfate
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.
- Conditions
- Iron-deficiency, Iron Deficiency Anaemia Due to Dietary Causes, Iron Deficiency Anemia Treatment, Iron Deficiency Anemia
- Being tested
- Ferrous sulfate, Ferrous sulfate-enriched Aspergillus oryzae (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.
Ferrous sulfateDietary supplement
2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron)
Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)Dietary 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: Ferrous sulfate |
| Ferrous sulfate-enriched Aspergillus oryzae (Ao iron) | Experimental | Ao iron supplements containing 54 mg elemental iron Receives: Dietary Supplement: Ferrous sulfate-enriched Aspergillus oryzae (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: Time Frame: 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: Time Frame: 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: Time Frame: 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: Time Frame: 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 posted9 Mar 2023
- Study start14 Jun 2022
- Primary completion2 Aug 2022
- Study completion2 Aug 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.
- 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
- Model description
- Dietary Supplement: FeSO4 Dietary Supplement: Ao iron
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Manju B. Reddy, Iowa State University
- Investigators
- Manju B Reddy, Ph.D., Principal investigator, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762380
- Sponsor's protocol ID
- IVFE
- Status last verified
- Sep 2022
- First submitted
- 28 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Fecal Fermentation Following Ingestion of Iron-enriched Aspergillus Oryzae or Iron Sulfate
- ClinicalTrials.gov ID
- NCT05762380
- Acronym / sponsor ID
- IVFE
- Conditions
- Iron-deficiency, Iron Deficiency Anaemia Due to Dietary Causes, Iron Deficiency Anemia Treatment, Iron Deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 9 Mar 2023 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Dietary Supplement: FeSO4 Dietary Supplement: Ao iron
| Arm | Type | Receives |
|---|---|---|
| Ferrous sulfate (FeSO4) | Active comparator | Dietary Supplement: Ferrous sulfateFeSO4 supplements containing 54 mg elemental iron |
| Ferrous sulfate-enriched Aspergillus oryzae (Ao iron) | Experimental | Dietary Supplement: Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)Ao iron supplements containing 54 mg elemental iron |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
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 |
|---|---|---|
| Ferrous sulfate2 FeSO4 supplements containing 27 mg elemental iron/supplements (54 mg total iron) | Dietary supplement | Ferrous sulfate (FeSO4) |
| Ferrous sulfate-enriched Aspergillus oryzae (Ao iron)2 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: 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: 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: Time Frame: 0-24 hours
Individual fecal short chain fatty acid (SCFA) concentration
Time frame: 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 9 Mar 2023.
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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.
Manju B Reddy, Ph.D. principal investigator
Iowa State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous sulfate and Ferrous sulfate-enriched Aspergillus oryzae (Ao iron) in people with Iron-deficiency and Iron Deficiency Anaemia Due to Dietary Causes, run by Iowa 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 5 inclusion and 8 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 9 Mar 2023. 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: 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 9 Mar 2023.