Iron AbsorptionNCT03586245
Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Isotope Methodology
A study testing Ferric pyrophosphate, Aspiron and Ferrous sulfate in people with Iron Absorption, run by Iowa State University.
Trial summary
The objective of this study was to compare the iron absorption from ferric pyrophosphate enriched Aspergillus oryzae (ASP-p) to commonly used ferric pyrophosphate (FePP) and ferrous sulfate (FeSO4) when fortified in chicken bouillon, using stable isotope methodology. 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 Absorption
- What is being tested?
- Ferric pyrophosphate, Aspiron and Ferrous sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 28 Oct 2016to 20 Jun 2017
- 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
- Suboptimal iron stores (Serum ferritin < 40 µg/L)
- BMI in range 18.5 - 24.9 kg/m2
- Willing to consumed meals containing iron supplement
- Willing to discontinue blood donation two weeks prior and during the study
- Willing to discontinue vitamin and mineral supplement use during the study
- Willing to provide a 15 ml blood for initial screening and 30 ml blood during the study (15 ml at each visit for 2 times in 24 days)
- Willing to attend 8 lab visits during the study
Who cannot join
- Pregnant
- Lactating
- Smoker
- Anemic (hemoglobin < 120 g/L)
- Has gastrointestinal disease/condition that can affect absorption
- Vegetarian
- Allergic to corn, wheat, soybean nor fungal supplements
About this study
Official title: Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Iron Isotope Methodology.
The objective of this study was to compare the iron absorption from ferric pyrophosphate enriched Aspergillus oryzae (ASP-p) to commonly used ferric pyrophosphate (FePP) and ferrous sulfate (FeSO4) when fortified in chicken bouillon, using stable isotope methodology.
Read the detailed description
Iron deficiency anemia (IDA) remains the most common nutrient deficiency, globally. Consequences such as decreased cognition, growth impairment, and morbidity and mortality arise from inadequate iron intake. Many technological challenges are presented in fortifying foods with iron, as inorganic iron salts are known to cause organoleptic problems in the food. As a result, finding an iron fortificant that doesn't alter taste, smell or stability of the food is ideal, however most suitable iron fortificants contain low bioavailability. Thirty-five non-anemic female subjects with ferritin ≤ 40 µg/L were recruited for both studies (17 in study I; 18 in study II). In both studies, each meal contained a total of 4.2 mg of added iron fortificants to a test meal containing 6.6 g of chicken bouillon. Participants were randomized to consume either meal A or B, followed by B or C. In study I, subjects consumed a total of 10 mg 57Fe as FePP and 2 mg 58Fe as ASP-p each over three consecutive days. Study II, subjects consumed a total of 10 mg 57Fe as FeSO4 and 2 mg 58Fe as ASP-p over 2 weekends. Blood samples collected at baseline were used to measure iron status indicators such as serum ferritin, C-reactive protein, hepcidin and hematocrit. Fourteen days following final isotope dosing, whole blood samples were collected and the fractional iron absorption of each iron fortificant containing labelled stable isotopes was measured via thermal ionization mass spectrometry with estimation of 80% incorporation into the hemoglobin.
- Conditions
- Iron Absorption
- Being tested
- Ferric pyrophosphate, Aspiron, Ferrous sulfate
- Keywords
- Iron Bioavailability, Iron Fortification, ferrous sulfate, ferric pyrophosphate, aspergillus oryzae, stable isotope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric pyrophosphateDietary supplement
57 Iron isotopically labeled FePP powder.
AspironDietary supplement
58 Iron isotope intrinsically labeled Aspergillus oryzae.
Ferrous sulfateDietary supplement
57 Iron isotopically labeled FeSO4 powder.
| Study group | Role | What they receive |
|---|---|---|
| Ferric pyrophosphate | Active comparator | Study I group was required to consume a total of 3 meals. Each meal contained 4.2 mg added iron compounds.
* 57FePP (95.8%) 3.49 mg
* Aspergillus oryzae (unenriched) 0.025 mg
* FePP natural abundance 0.685 mg.
Subjects received iron fortificants in a meal composed of zucchini, cabbage, carrot (42g each), onion (24g), corn oil (6.3 g), jasmine rice (75g dw), and flavored granulated chicken bouillon (6.6g). All meals were consumed in a fasted state with nothing to eat or drink (besides water) for 3 hours following consumption. Receives: Dietary Supplement: Ferric pyrophosphate |
| Aspiron | Experimental | The Aspiron group was required to follow the same protocol as the 57Fe as FePP, with the exception of consuming 58Fe ASP.
* ASP-p (8% Fe; natural abundance) 3.516 mg
* 58ASP-p (5% Fe; 99.5% enrichment) 0.68 mg
* 4.2 total mg of Fe Receives: Dietary Supplement: Aspiron |
| Ferrous sulfate | Other | The FeSO4 study group was required to consume a total of 3 meals. Each meal contained 4.2 mg added iron compounds. .
* Aspergillus oryzae (unenriched) 0.027 mg
* 57FeSO4 (95.4%) 3.18 mg
* 4.2 total mg of Fe Receives: Dietary Supplement: Ferrous sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Fractional Iron absorption of FePP, FeS)4 and ASP
Isotope enrichment in the whole blood samples after 14 days of feeding the meals assuming 80% incorporation of iron into the hemoglobin. Circulating iron was calculated from blood volume, height (cm), weight (kg) and hemoglobin (g/dL).
Measured: Whole blood collected 14 days following isotope consumption to allow for enrichment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study start28 Oct 2016
- Primary completion3 May 2017
- Study completion20 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron AbsorptionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects consumed two stable isotopes (57Fe and 58Fe). Study I, three consecutive days of meal A followed by crossover of three days meal B were consumed. Study II was a crossover between meal B and meal C.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 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
- NCT03586245
- Sponsor's protocol ID
- ASP Study
- Status last verified
- Aug 2016
- First submitted
- 6 Jul 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Publish results in a journal.
Publications
Bries AE, Hurrell RF, Reddy MB. Iron Absorption from Bouillon Fortified with Iron-Enriched Aspergillus oryzae Is Higher Than That Fortified with Ferric Pyrophosphate in Young Women. J Nutr. 2020 May 1;150(5):1109-1115. doi: 10.1093/jn/nxaa035.
PubMed 32073619
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Iron Isotope Methodology.
- ClinicalTrials.gov ID
- NCT03586245
- Acronym / sponsor ID
- ASP Study
- Conditions
- Iron Absorption
- Keywords
- Iron Bioavailability, Iron Fortification, ferrous sulfate, ferric pyrophosphate, aspergillus oryzae, stable isotope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- 28 Oct 2016 (actual)
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 13 Jul 2018 (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 iron absorption from ferric pyrophosphate enriched Aspergillus oryzae (ASP-p) to commonly used ferric pyrophosphate (FePP) and ferrous sulfate (FeSO4) when fortified in chicken bouillon, using stable isotope methodology.
Detailed description
Iron deficiency anemia (IDA) remains the most common nutrient deficiency, globally. Consequences such as decreased cognition, growth impairment, and morbidity and mortality arise from inadequate iron intake. Many technological challenges are presented in fortifying foods with iron, as inorganic iron salts are known to cause organoleptic problems in the food. As a result, finding an iron fortificant that doesn't alter taste, smell or stability of the food is ideal, however most suitable iron fortificants contain low bioavailability. Thirty-five non-anemic female subjects with ferritin ≤ 40 µg/L were recruited for both studies (17 in study I; 18 in study II). In both studies, each meal contained a total of 4.2 mg of added iron fortificants to a test meal containing 6.6 g of chicken bouillon. Participants were randomized to consume either meal A or B, followed by B or C. In study I, subjects consumed a total of 10 mg 57Fe as FePP and 2 mg 58Fe as ASP-p each over three consecutive days. Study II, subjects consumed a total of 10 mg 57Fe as FeSO4 and 2 mg 58Fe as ASP-p over 2 weekends. Blood samples collected at baseline were used to measure iron status indicators such as serum ferritin, C-reactive protein, hepcidin and hematocrit. Fourteen days following final isotope dosing, whole blood samples were collected and the fractional iron absorption of each iron fortificant containing labelled stable isotopes was measured via thermal ionization mass spectrometry with estimation of 80% incorporation into the hemoglobin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Subjects consumed two stable isotopes (57Fe and 58Fe). Study I, three consecutive days of meal A followed by crossover of three days meal B were consumed. Study II was a crossover between meal B and meal C.
| Arm | Type | Receives |
|---|---|---|
| Ferric pyrophosphate | Active comparator | Dietary Supplement: Ferric pyrophosphateStudy I group was required to consume a total of 3 meals. Each meal contained 4.2 mg added iron compounds. * 57FePP (95.8%) 3.49 mg * Aspergillus oryzae (unenriched) 0.025 mg * FePP natural abundance 0.685 mg. Subjects received iron fortificants in a meal composed of zucchini, cabbage, carrot (42g each), onion (24g), corn oil (6.3 g), jasmine rice (75g dw), and flavored granulated chicken bouillon (6.6g). All meals were consumed in a fasted state with nothing to eat or drink (besides water) for 3 hours following consumption. |
| Aspiron | Experimental | Dietary Supplement: AspironThe Aspiron group was required to follow the same protocol as the 57Fe as FePP, with the exception of consuming 58Fe ASP. * ASP-p (8% Fe; natural abundance) 3.516 mg * 58ASP-p (5% Fe; 99.5% enrichment) 0.68 mg * 4.2 total mg of Fe |
| Ferrous sulfate | Other | Dietary Supplement: Ferrous sulfateThe FeSO4 study group was required to consume a total of 3 meals. Each meal contained 4.2 mg added iron compounds. . * Aspergillus oryzae (unenriched) 0.027 mg * 57FeSO4 (95.4%) 3.18 mg * 4.2 total mg of Fe |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Suboptimal iron stores (Serum ferritin < 40 µg/L)
- BMI in range 18.5 - 24.9 kg/m2
- Willing to consumed meals containing iron supplement
- Willing to discontinue blood donation two weeks prior and during the study
- Willing to discontinue vitamin and mineral supplement use during the study
Key exclusion criteria (7 listed)
- Pregnant
- Lactating
- Smoker
- Anemic (hemoglobin < 120 g/L)
- Has gastrointestinal 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 |
|---|---|---|
| Ferric pyrophosphate57 Iron isotopically labeled FePP powder. | Dietary supplement | Ferric pyrophosphate |
| Aspiron58 Iron isotope intrinsically labeled Aspergillus oryzae. | Dietary supplement | Aspiron |
| Ferrous sulfate57 Iron isotopically labeled FeSO4 powder. | Dietary supplement | Ferrous sulfate |
Primary outcome
Percentage Fractional Iron absorption of FePP, FeS)4 and ASP
Time frame: Whole blood collected 14 days following isotope consumption to allow for enrichment.
Isotope enrichment in the whole blood samples after 14 days of feeding the meals assuming 80% incorporation of iron into the hemoglobin. Circulating iron was calculated from blood volume, height (cm), weight (kg) and hemoglobin (g/dL).
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 23 Jul 2018.
- Derived from this study: PubMed 32073619Bries AE, Hurrell RF, Reddy MB. Iron Absorption from Bouillon Fortified with Iron-Enriched Aspergillus oryzae Is Higher Than That Fortified with Ferric Pyrophosphate in Young Women. J Nutr. 2020 May 1;150(5):1109-1115. doi: 10.1093/jn/nxaa035.
- Individual participant dataSharing planned: No. Publish results in a journal.
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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, PhD principal investigator
Iowa State University
Questions about this trial
What is this clinical trial studying?
A study testing Ferric pyrophosphate, Aspiron and Ferrous sulfate in people with Iron Absorption, 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 7 inclusion and 7 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 23 Jul 2018. 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?
Percentage Fractional Iron absorption of FePP, FeS)4 and ASP (time frame: Whole blood collected 14 days following isotope consumption to allow for enrichment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03586245, which also lists 1 linked publication.
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 23 Jul 2018.