Iron-deficiencyIFACNCT03895424
Iron Isotope Study of an Iron Fatty Acid Complex
A study testing IFAC and MIFAC in people with Iron-deficiency, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
The study aims at assessing the iron (Fe) bioavailability from a newly developed iron compound - an iron fatty acid complex. The iron from the compound is hypothesized to have a higher absorption rate than commonly available supplements in the market. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- IFAC and MIFAC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Jan 2019to 20 Jun 2019
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age of 18 - 40 years old
- marginal iron status (ferritin <25 ng/ml; measured by study coordinator)
- body weight up to 65 kg
- normal body mass index (bodyweight [kg] / (height [m])2 = 18.5 - 25)
- do not take any vitamin or mineral supplements two weeks before and during the study.
- do not have a metabolic, gastrointestinal or chronic diseases
- able to communicate in and comprehend English language
Who cannot join
- pregnant or breast-feeding
- on long-term medication (except oral contraceptive)
- elevated C-reactive Protein (>5mg/L; will be measured by study coordinator)
- medium or strong anemic (hemoglobin <9.0 g/dL; will be measured by study coordinator)
- donated blood within the last 4 months before the study start date
- taking part in another clinical study at the same time or had within the last 30 days before the study date
Show all 10Show fewer
- participated in an earlier study using iron stable isotopes.
- eating disorder or a strong allergy.
- cannot be expected to comply with study protocol (e.g. not available on certain study appointments or difficulties with blood sampling)
- unable to understand the information sheet and the informed consent form due to cognitive or language reasons
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Lab of Human Nutrition, ETH Zurich
Zurich, Canton of Zurich, 8092
About this study
Official title: An Iron Isotope Study in Humans to Evaluate the Iron Bioavailability of a Novel Iron Compound - Iron Fatty Acid Complex
The study aims at assessing the iron (Fe) bioavailability from a newly developed iron compound - an iron fatty acid complex. The iron from the compound is hypothesized to have a higher absorption rate than commonly available supplements in the market. The study is a cross over, human iron isotope study with three arms where participants consume the experimental dietary products in a randomized fashion. The study duration is of 45 days - from the day of the capsule administration till the last blood sampling point
Read the detailed description
Iron deficiency remains a major public health concern in both industrialized and non-industrialized (developing) countries. Most supplements in the present day, to address the problem of iron deficiency, are in the form of ferrous salts, especially ferrous sulfate. Ferrous salts are absorbed by the non-heme iron pathway involving the Divalent Metal Transporter 1 (DMT-1) receptor, where the absorption rate is 20% of the total iron content. The common strategy of the food supplement industries is to increase the iron load in the supplements to provide the necessary amount of iron, compensating for the low absorption rate. However, these have side effects associated with the high dosage. Instead of a high dosage, a more effective strategy would be to incorporate the iron in a way that the absorption rate is maximized. The intervention product, an iron fatty acid complex (IFAC), containing 12 mg of iron, is expected to be absorbed as effective as any ferrous sulfate supplement in the market due to the alternative metabolic route that is hypothesized to be taken by the complex.
The first week of the study comprises of the administration of the capsules containing the complexes to the participants on day 1 , day 3 and day 5 of the study respectively. Blood samples are collected on day 10,20, 30 and 40 and 160 days after the last day of the capsule administration..
The primary objectives of this trial are:
To assess the iron bioavailability from the developed iron salt fatty acid complexes (IFAC) and micro-emulsified iron fatty acid complex (MIFAC) and compare it with the bioavailability of the reference ferrous sulfate (FeSO4) To investigate whether the MIFAC promotes absorption compared to IFAC and the reference.
Fractional iron absorption from the three intervention products will be calculated based on the shift of the stable iron isotope ratios in collected blood samples at 10, 20, 30, 40 and 160 days after administration of the stable isotopically labelled capsules. Stable iron isotope ratios will be determined by mass spectrometry.
- Conditions
- Iron-deficiency
- Being tested
- IFAC, MIFAC, Control Ferrous Sulfate
- Keywords
- Iron, Isotope study, Fatty Acid
- 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.
IFACDietary supplement
This intervention will contain the iron fatty acid complex in a capsule. The complex will be labelled with the iron isotope 58Fe
MIFACDietary supplement
This intervention will contain the micellarized form of the iron fatty acid complex in a capsule. The complex will be labelled with the iron isotope with 57Fe
Control Ferrous SulfateDietary supplement
This intervention will contain ferrous sulfate in the form of a solution labelled with the iron isotope 54Fe. A capsule with the same amount of fat as in the other arms will be administered to the participants
| Study group | Role | What they receive |
|---|---|---|
| Iron Fatty Acid Complex (IFAC) | Experimental | The iron fatty acid complex encapsulated and administered to the participants Receives: Dietary Supplement: IFAC |
| Micellarized iron fatty acid complex (MIFAC) | Experimental | Micellarized form of the iron fatty acid complex which is enscapsulated and administered to the participants Receives: Dietary Supplement: MIFAC |
| Control Ferrous Sulfate | Active comparator | Ferrous sulfate that is provided in the form of a solution along with a capsule that contains the same amount of fat that is present in the other two arms. Receives: Dietary Supplement: Control Ferrous Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional iron absorption from IFAC
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Measured: Day 10 of the study
Fractional iron absorption from IFAC
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Measured: Day 20 of the study
Fractional iron absorption from IFAC
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Measured: Day 30 of the study
Fractional iron absorption from IFAC
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Measured: Day 40 of the study
Fractional iron absorption from IFAC
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Measured: Day 160 of the study
Fractional iron absorption from MIFAC
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Measured: Day 10 of the study
Fractional iron absorption from MIFAC
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Measured: Day 20 of the study
Fractional iron absorption from MIFAC
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Measured: Day 30 of the study
Fractional iron absorption from MIFAC
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Measured: Day 40 of the study
Fractional iron absorption from MIFAC
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Measured: Day 160 of the study
Fractional iron absorption from Control Ferrous Sulfate
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Measured: Day 10 of the study
Fractional iron absorption from Control Ferrous Sulfate
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Measured: Day 20 of the study
Fractional iron absorption from Control Ferrous Sulfate
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Measured: Day 30 of the study
Fractional iron absorption from Control Ferrous Sulfate
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Measured: Day 40 of the study
Fractional iron absorption from Control Ferrous Sulfate
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Measured: Day 160 of the study
Secondary outcomes (16)
Haemoglobin
Haemoglobin status of the participants will be measured to check for anaemia status
Measured: Day 1 of the study
Haemoglobin
Haemoglobin status of the participants will be measured to check for anaemia status
Measured: Day 10 of the study
Haemoglobin
Haemoglobin status of the participants will be measured to check for anaemia status
Measured: Day 20 of the study
Haemoglobin
Haemoglobin status of the participants will be measured to check for anaemia status
Measured: Day 30 of the study
Haemoglobin
Haemoglobin status of the participants will be measured to check for anaemia status
Measured: Day 40 of the study
Haemoglobin
Haemoglobin status of the participants will be measured to check for anaemia status
Measured: Day 160 of the study
Ferritin
Ferritin levels will be measured to assess the iron stores in the participants.
Measured: Day 1 of the study
Ferritin
Ferritin levels will be measured to assess the iron stores in the participants.
Measured: Day 10 of the study
Ferritin
Ferritin levels will be measured to assess the iron stores in the participants.
Measured: Day 20 of the study
Ferritin
Ferritin levels will be measured to assess the iron stores in the participants.
Measured: Day 30 of the study
Ferritin
Ferritin levels will be measured to assess the iron stores in the participants.
Measured: Day 40 of the study
C-reactive Protein
Inflammation status of the participants will be measured since it has an effect on iron absorption
Measured: Day 1 of the study
C-reactive Protein
Inflammation status of the participants will be measured since it has an effect on iron absorption
Measured: Day 10 of the study
C-reactive Protein
Inflammation status of the participants will be measured since it has an effect on iron absorption
Measured: Day 20 of the study
C-reactive Protein
Inflammation status of the participants will be measured since it has an effect on iron absorption
Measured: Day 30 of the study
C-reactive Protein
Inflammation status of the participants will be measured since it has an effect on iron absorption
Measured: Day 40 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start7 Jan 2019
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Mibelle AG
- Responsible party
- Sponsor
- Investigators
- Michael Zimmermann, PhD, Principal investigator, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895424
- Sponsor's protocol ID
- IFAC
- Acronym
- IFAC
- Status last verified
- Aug 2019
- First submitted
- 7 Mar 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Iron Isotope Study in Humans to Evaluate the Iron Bioavailability of a Novel Iron Compound - Iron Fatty Acid Complex
- ClinicalTrials.gov ID
- NCT03895424
- Acronym / sponsor ID
- IFAC / IFAC
- Conditions
- Iron-deficiency
- Keywords
- Iron, Isotope study, Fatty Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Mibelle AG
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 29 Mar 2019 (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 study aims at assessing the iron (Fe) bioavailability from a newly developed iron compound - an iron fatty acid complex. The iron from the compound is hypothesized to have a higher absorption rate than commonly available supplements in the market. The study is a cross over, human iron isotope study with three arms where participants consume the experimental dietary products in a randomized fashion. The study duration is of 45 days - from the day of the capsule administration till the last blood sampling point
Detailed description
Iron deficiency remains a major public health concern in both industrialized and non-industrialized (developing) countries. Most supplements in the present day, to address the problem of iron deficiency, are in the form of ferrous salts, especially ferrous sulfate. Ferrous salts are absorbed by the non-heme iron pathway involving the Divalent Metal Transporter 1 (DMT-1) receptor, where the absorption rate is 20% of the total iron content. The common strategy of the food supplement industries is to increase the iron load in the supplements to provide the necessary amount of iron, compensating for the low absorption rate. However, these have side effects associated with the high dosage. Instead of a high dosage, a more effective strategy would be to incorporate the iron in a way that the absorption rate is maximized. The intervention product, an iron fatty acid complex (IFAC), containing 12 mg of iron, is expected to be absorbed as effective as any ferrous sulfate supplement in the market due to the alternative metabolic route that is hypothesized to be taken by the complex.
The first week of the study comprises of the administration of the capsules containing the complexes to the participants on day 1 , day 3 and day 5 of the study respectively. Blood samples are collected on day 10,20, 30 and 40 and 160 days after the last day of the capsule administration..
The primary objectives of this trial are:
To assess the iron bioavailability from the developed iron salt fatty acid complexes (IFAC) and micro-emulsified iron fatty acid complex (MIFAC) and compare it with the bioavailability of the reference ferrous sulfate (FeSO4) To investigate whether the MIFAC promotes absorption compared to IFAC and the reference.
Fractional iron absorption from the three intervention products will be calculated based on the shift of the stable iron isotope ratios in collected blood samples at 10, 20, 30, 40 and 160 days after administration of the stable isotopically labelled capsules. Stable iron isotope ratios will be determined by mass spectrometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Iron Fatty Acid Complex (IFAC) | Experimental | Dietary Supplement: IFACThe iron fatty acid complex encapsulated and administered to the participants |
| Micellarized iron fatty acid complex (MIFAC) | Experimental | Dietary Supplement: MIFACMicellarized form of the iron fatty acid complex which is enscapsulated and administered to the participants |
| Control Ferrous Sulfate | Active comparator | Dietary Supplement: Control Ferrous SulfateFerrous sulfate that is provided in the form of a solution along with a capsule that contains the same amount of fat that is present in the other two arms. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age of 18 - 40 years old
- marginal iron status (ferritin <25 ng/ml; measured by study coordinator)
- body weight up to 65 kg
- normal body mass index (bodyweight [kg] / (height [m])2 = 18.5 - 25)
- do not take any vitamin or mineral supplements two weeks before and during the study.
Key exclusion criteria (10 listed)
- pregnant or breast-feeding
- on long-term medication (except oral contraceptive)
- elevated C-reactive Protein (>5mg/L; will be measured by study coordinator)
- medium or strong anemic (hemoglobin <9.0 g/dL; will be measured by study coordinator)
- donated blood within the last 4 months before the study start date
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 |
|---|---|---|
| IFACThis intervention will contain the iron fatty acid complex in a capsule. The complex will be labelled with the iron isotope 58Fe | Dietary supplement | Iron Fatty Acid Complex (IFAC) |
| MIFACThis intervention will contain the micellarized form of the iron fatty acid complex in a capsule. The complex will be labelled with the iron isotope with 57Fe | Dietary supplement | Micellarized iron fatty acid complex (MIFAC) |
| Control Ferrous SulfateThis intervention will contain ferrous sulfate in the form of a solution labelled with the iron isotope 54Fe. A capsule with the same amount of fat as in the other arms will be administered to the participants | Dietary supplement | Control Ferrous Sulfate |
Primary outcome
Fractional iron absorption from IFAC
Time frame: Day 10 of the study
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Fractional iron absorption from IFAC
Time frame: Day 20 of the study
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Fractional iron absorption from IFAC
Time frame: Day 30 of the study
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Fractional iron absorption from IFAC
Time frame: Day 40 of the study
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Fractional iron absorption from IFAC
Time frame: Day 160 of the study
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Fractional iron absorption from MIFAC
Time frame: Day 10 of the study
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Fractional iron absorption from MIFAC
Time frame: Day 20 of the study
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Fractional iron absorption from MIFAC
Time frame: Day 30 of the study
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Fractional iron absorption from MIFAC
Time frame: Day 40 of the study
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Fractional iron absorption from MIFAC
Time frame: Day 160 of the study
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Fractional iron absorption from Control Ferrous Sulfate
Time frame: Day 10 of the study
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Fractional iron absorption from Control Ferrous Sulfate
Time frame: Day 20 of the study
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Fractional iron absorption from Control Ferrous Sulfate
Time frame: Day 30 of the study
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Fractional iron absorption from Control Ferrous Sulfate
Time frame: Day 40 of the study
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
Fractional iron absorption from Control Ferrous Sulfate
Time frame: Day 160 of the study
The primary outcome is the fractional iron absorption, which will be compared in predefined comparisons from the three different capsules that will be administered to the study participants. Relative bioavailability, defined as the ratio of fractional absorption relative to the reference dose (absorption measured from encapsulated FeSO4), will be also compared in predefined comparisons.
16 secondary outcomes
Haemoglobin
Time frame: Day 1 of the study
Haemoglobin
Time frame: Day 10 of the study
Haemoglobin
Time frame: Day 20 of the study
Haemoglobin
Time frame: Day 30 of the study
Haemoglobin
Time frame: Day 40 of the study
Haemoglobin
Time frame: Day 160 of the study
Ferritin
Time frame: Day 1 of the study
Ferritin
Time frame: Day 10 of the study
Ferritin
Time frame: Day 20 of the study
Ferritin
Time frame: Day 30 of the study
Ferritin
Time frame: Day 40 of the study
C-reactive Protein
Time frame: Day 1 of the study
C-reactive Protein
Time frame: Day 10 of the study
C-reactive Protein
Time frame: Day 20 of the study
C-reactive Protein
Time frame: Day 30 of the study
C-reactive Protein
Time frame: Day 40 of the study
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 28 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
Michael Zimmermann, PhD principal investigator
Swiss Federal Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IFAC and MIFAC in people with Iron-deficiency, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 10 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 28 Aug 2019. 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 Switzerland. 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?
Fractional iron absorption from IFAC (time frame: Day 10 of the study). The study lists 15 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 28 Aug 2019.