Iron BioavailabilityNCT03156725
Assessment of Iron Absorption From Aspergillus Oryzae
A study testing Ferrous Sulfate and Aspiron in people with Iron Bioavailability, run by Iowa State University.
Trial summary
The objective of this study was to compare the absorption of a new iron product, iron enriched Aspergillus oryzae to ferrous sulfate in humans using a double stable-isotope technique. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Bioavailability
- What is being tested?
- Ferrous Sulfate and Aspiron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 19 May 2014to 4 Jun 2016
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Marginal iron status (Serum ferritin <30ug/L)
- BMI in the range 18.5-24.9 kg/m2
- Willing to discontinue vitamin and mineral supplements 2 weeks prior and during the study
- Willing to consume stable iron isotope labelled supplement
- Willing to stop getting blood drawn 2 weeks prior to the study and during the study
- Willing to give multiple blood samples at beginning and end of study
Who cannot join
- Pregnant
- Lactating
- Smoker
- Anemic (hemoglobin < 120 g/L)
- Has gastro-intestinal disease/condition that can affect absorption
- Allergic to any of the meal components
About this study
Official title: Iron Absorption From Iron-enriched Aspergillus Oryzae is Similar to Ferrous Sulfate
The objective of this study was to compare the absorption of a new iron product, iron enriched Aspergillus oryzae to ferrous sulfate in humans using a double stable-isotope technique.
Read the detailed description
Iron deficiency anemia (IDA) remains a health crisis worldwide, especially among productive age women and children. Primarily, inorganic iron salts are being used as iron supplementation to treat IDA and are added to food to improve the nutritional value of the daily diet, however side effects and/or low absorption with diets are a result, limiting the impact on IDA. Sixteen female subject, who were 18-35 years, non-pregnancy, non-anemia with marginal lower iron status (ferritin cut-off value <30ug/L) were recruited in this study. Subjects were randomized to orally consume test meal with stable iron isotopes Fe57 (10mg) in sulfate form and Fe58 (2mg) and 8 mg natural abundance iron in Aspiron, in two visits. Blood samples were collected at baseline and two weeks to assess isotope enrichment and iron status indicators, such as hepcidin and ferritin were measured.
- Conditions
- Iron Bioavailability
- Being tested
- Ferrous Sulfate, Aspiron
- Keywords
- Iron Bioavailability, hepcidin, ferritin, iron absorption, iron status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous SulfateDrug
AspironDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Ferrous Sulfate | Experimental | The ferrous sulfate group was required to consume a test containing ferrous sulfate (10 mg of 57Fe). Participants received a meal containing 17.6 g egg albumin, 45 g corn syrup solids, 17.5 g corn oil, 6 ml vanilla extract, and 100 ml of distilled water. Receives: Drug: Ferrous Sulfate |
| Aspiron | Experimental | The Asprion group was required to follow the same protocol as the 57Fe experimental group, with the exception of taking A. Oryzae containing (8 mg natural abundace Fe and 2 mg 58Fe. Meals composition was similar to ferrous sulafte group. Receives: Dietary Supplement: Aspiron |
What is being measured
The primary outcome is the main question the study is designed to answer.
iron absorption
Isotope enrichment in the blood samples
Measured: 15 days
Secondary outcomes (1)
iron status
hepcidin and ferritin
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start19 May 2014
- Primary completion14 Sep 2014
- Study completion4 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron BioavailabilityStudies 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
- Single group
- Model description
- Subjects were two meals on two consecutive days with the stable isotopes.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 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, PhD, Principal investigator, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156725
- Sponsor's protocol ID
- HIFS study
- Status last verified
- May 2017
- First submitted
- 12 May 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publication in a journal
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Absorption From Iron-enriched Aspergillus Oryzae is Similar to Ferrous Sulfate
- ClinicalTrials.gov ID
- NCT03156725
- Acronym / sponsor ID
- HIFS study
- Conditions
- Iron Bioavailability
- Keywords
- Iron Bioavailability, hepcidin, ferritin, iron absorption, iron status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- 19 May 2014 (actual)
- Primary completion
- 14 Sep 2014 (actual)
- Study completion
- 4 Jun 2016 (actual)
- First posted
- 17 May 2017 (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 objective of this study was to compare the absorption of a new iron product, iron enriched Aspergillus oryzae to ferrous sulfate in humans using a double stable-isotope technique.
Detailed description
Iron deficiency anemia (IDA) remains a health crisis worldwide, especially among productive age women and children. Primarily, inorganic iron salts are being used as iron supplementation to treat IDA and are added to food to improve the nutritional value of the daily diet, however side effects and/or low absorption with diets are a result, limiting the impact on IDA. Sixteen female subject, who were 18-35 years, non-pregnancy, non-anemia with marginal lower iron status (ferritin cut-off value <30ug/L) were recruited in this study. Subjects were randomized to orally consume test meal with stable iron isotopes Fe57 (10mg) in sulfate form and Fe58 (2mg) and 8 mg natural abundance iron in Aspiron, in two visits. Blood samples were collected at baseline and two weeks to assess isotope enrichment and iron status indicators, such as hepcidin and ferritin were measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Subjects were two meals on two consecutive days with the stable isotopes.
| Arm | Type | Receives |
|---|---|---|
| Ferrous Sulfate | Experimental | Drug: Ferrous SulfateThe ferrous sulfate group was required to consume a test containing ferrous sulfate (10 mg of 57Fe). Participants received a meal containing 17.6 g egg albumin, 45 g corn syrup solids, 17.5 g corn oil, 6 ml vanilla extract, and 100 ml of distilled water. |
| Aspiron | Experimental | Dietary Supplement: AspironThe Asprion group was required to follow the same protocol as the 57Fe experimental group, with the exception of taking A. Oryzae containing (8 mg natural abundace Fe and 2 mg 58Fe. Meals composition was similar to ferrous sulafte group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Marginal iron status (Serum ferritin <30ug/L)
- BMI in the range 18.5-24.9 kg/m2
- Willing to discontinue vitamin and mineral supplements 2 weeks prior and during the study
- Willing to consume stable iron isotope labelled supplement
- Willing to stop getting blood drawn 2 weeks prior to the study and during the study
Key exclusion criteria (6 listed)
- Pregnant
- Lactating
- Smoker
- Anemic (hemoglobin < 120 g/L)
- Has gastro-intestinal disease/condition that can affect absorption
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 Sulfate | Drug | Ferrous Sulfate |
| Aspiron | Dietary supplement | Aspiron |
Primary outcome
iron absorption
Time frame: 15 days
Isotope enrichment in the blood samples
1 secondary outcome
iron status
Time frame: 15 days
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 17 May 2017.
- Individual participant dataSharing planned: No. Publication in a journal
Related trials for Iron Bioavailability
Active, not recruiting
Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency
Iron Deficiency (Without Anemia)
Recruiting
A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females
Iron Deficiencies, Low Ferritin
Recruiting
Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya
Iron Absorption, Iron Deficiencies
Recruiting
Effect of Chitin and Ascorbic Acid on Dietary Insect Iron Absorption
Iron Deficiency (Without Anemia)
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, PhD principal investigator
Iowa State University
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous Sulfate and Aspiron in people with Iron Bioavailability, run by Iowa State University.
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 6 inclusion and 6 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 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
iron absorption (time frame: 15 days). 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 17 May 2017.