Iron AbsorptionNCT02979132
Iron Long-Term Labelling Study Switzerland
A study testing Eisensulfat LOMAPHARM 50 mg, Ferinject(R) and iron fortified biscuits in people with Iron Absorption, run by Prof. Michael B. Zimmermann at 1 site in Switzerland.
Trial summary
Conventional indirect indicators of iron status, using serum and red blood cell biomarkers, are confounded by inflammation from common infections and are therefore of limited use in populations carrying a high burden of infection and inflammation, as for example women of reproductive age in malaria endemic areas in… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Absorption
- What is being tested?
- Eisensulfat LOMAPHARM 50 mg, Ferinject(R) and iron fortified biscuits
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2017to 31 Mar 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have participated in a former absorption study in our lab,
- Signed written informed consent to participate in the new study,
- Serum ferritin < 25 µg/L
Who cannot join
- Anaemia (Hb < 117 g/L),
- Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement),
- Allergic or similar reactions against iron supplements,
- Known fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency,
- Known hypersensitivity to ponceau R4 and ponceau R4 aluminium salt (E124)
- Continuous/long-term use of medication during the whole study (except for contraceptives),
Show all 14Show fewer
- Regular consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration (more than 3 consecutive days or more than 5 times within 14 days),
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 6 months,
- pregnancy or breast feeding,
- Intention to become pregnant during the course of the study,
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Enrollment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Human Nutrition Laboratory, ETH Zürich
Zurich, Canton of Zurich, 8092
About this study
Official title: Evaluation of the Validity of a Novel Isotope Dilution Method to Assess the Iron Status and Its Changes in Swiss Women
Conventional indirect indicators of iron status, using serum and red blood cell biomarkers, are confounded by inflammation from common infections and are therefore of limited use in populations carrying a high burden of infection and inflammation, as for example women of reproductive age in malaria endemic areas in developing countries. Even without the confounding effect of inflammation, current markers of iron status are insensitive to small changes in dietary iron and do not allow to establish associations between dietary, lifestyle and genetic factors and iron balance. With a new method based on the dilution of a previously administered and equilibrated stable isotope signal, an accurate measurement of long-term oral iron balance and absorption is possible, allowing the estimation of iron requirements and potentially providing fundamental guidance for supplementation and fortification programs in both healthy and chronically inflamed/infected patients. In the current study the novel methodology will be validated in generally healthy subjects with low iron status. The technique will be used to assess dietary and lifestyle determinants of iron status and to compare the effect on iron balance and iron status of three distinct, commonly used iron interventions: food fortification with iron; oral iron supplementation, and intravenous iron infusion.
- Conditions
- Iron Absorption
- Being tested
- Eisensulfat LOMAPHARM 50 mg, Ferinject(R), iron fortified biscuits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eisensulfat LOMAPHARM 50 mgDrug
Also called Eisentabletten
oral intake of an 'Eisensulfat LOMAPHARM 50 mg' tablet every morning for 90 days
Ferinject(R)Drug
Also called Iron Infusion
Single-dose Ferinject(R) administration
iron fortified biscuitsDietary supplement
Also called HUG-Biskuits
consumption of an iron-fortfied biscuit every morning for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Oral Iron Supplementation | Active comparator | Eisensulfat LOMAPHARM 50 mg administration for 90 days Receives: Drug: Eisensulfat LOMAPHARM 50 mg |
| Intravenous Iron Supplementation | Active comparator | Single-dose Ferinject(R) administration Receives: Drug: Ferinject(R) |
| Food Fortification with Iron | Active comparator | Consumption of iron-fortified biscuits (15 mg Fe in form of FeSO4) for 90 d Receives: Dietary Supplement: iron fortified biscuits |
What is being measured
The primary outcome is the main question the study is designed to answer.
iron isotope composition in blood
tracer to tracee rate in venous blood samples at different time points
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study start1 Sep 2017
- Primary completion31 Jul 2018
- Study completion31 Mar 2019 (estimated)
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Michael B. Zimmermann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979132
- Sponsor's protocol ID
- Fe_LTL_Swi
- Status last verified
- Oct 2018
- First submitted
- 29 Nov 2016
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Speich C, Mitchikpe CES, Cercamondi CI, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Direct assessment of body iron balance in women with and without iron supplementation using a long-term isotope dilution method in Benin and Switzerland. Am J Clin Nutr. 2021 Jun 1;113(6):1657-1669. doi: 10.1093/ajcn/nqaa433.
PubMed 33693464
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Validity of a Novel Isotope Dilution Method to Assess the Iron Status and Its Changes in Swiss Women
- ClinicalTrials.gov ID
- NCT02979132
- Acronym / sponsor ID
- Fe_LTL_Swi
- Conditions
- Iron Absorption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Prof. Michael B. ZimmermannUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 1 Dec 2016 (estimated)
- 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.
Conventional indirect indicators of iron status, using serum and red blood cell biomarkers, are confounded by inflammation from common infections and are therefore of limited use in populations carrying a high burden of infection and inflammation, as for example women of reproductive age in malaria endemic areas in developing countries. Even without the confounding effect of inflammation, current markers of iron status are insensitive to small changes in dietary iron and do not allow to establish associations between dietary, lifestyle and genetic factors and iron balance. With a new method based on the dilution of a previously administered and equilibrated stable isotope signal, an accurate measurement of long-term oral iron balance and absorption is possible, allowing the estimation of iron requirements and potentially providing fundamental guidance for supplementation and fortification programs in both healthy and chronically inflamed/infected patients. In the current study the novel methodology will be validated in generally healthy subjects with low iron status. The technique will be used to assess dietary and lifestyle determinants of iron status and to compare the effect on iron balance and iron status of three distinct, commonly used iron interventions: food fortification with iron; oral iron supplementation, and intravenous iron infusion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Iron Supplementation | Active comparator | Drug: Eisensulfat LOMAPHARM 50 mgEisensulfat LOMAPHARM 50 mg administration for 90 days |
| Intravenous Iron Supplementation | Active comparator | Drug: Ferinject(R)Single-dose Ferinject(R) administration |
| Food Fortification with Iron | Active comparator | Dietary Supplement: iron fortified biscuitsConsumption of iron-fortified biscuits (15 mg Fe in form of FeSO4) for 90 d |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Have participated in a former absorption study in our lab,
- Signed written informed consent to participate in the new study,
- Serum ferritin < 25 µg/L
Key exclusion criteria (14 listed)
- Anaemia (Hb < 117 g/L),
- Any metabolic, gastrointestinal, kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement),
- Allergic or similar reactions against iron supplements,
- Known fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency,
- Known hypersensitivity to ponceau R4 and ponceau R4 aluminium salt (E124)
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 |
|---|---|---|
| Eisensulfat LOMAPHARM 50 mgAlso: Eisentablettenoral intake of an 'Eisensulfat LOMAPHARM 50 mg' tablet every morning for 90 days | Drug | Oral Iron Supplementation |
| Ferinject(R)Also: Iron InfusionSingle-dose Ferinject(R) administration | Drug | Intravenous Iron Supplementation |
| iron fortified biscuitsAlso: HUG-Biskuitsconsumption of an iron-fortfied biscuit every morning for 90 days | Dietary supplement | Food Fortification with Iron |
Primary outcome
iron isotope composition in blood
Time frame: 9 months
tracer to tracee rate in venous blood samples at different time points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Derived from this study: PubMed 33693464Speich C, Mitchikpe CES, Cercamondi CI, Zeder C, Brittenham GM, Moretti D, Zimmermann MB. Direct assessment of body iron balance in women with and without iron supplementation using a long-term isotope dilution method in Benin and Switzerland. Am J Clin Nutr. 2021 Jun 1;113(6):1657-1669. doi: 10.1093/ajcn/nqaa433.
- Individual participant dataSharing planned: Undecided
Related trials for Iron Absorption
Active, not recruiting
The Effects of Acute Erythropoietin on Hepcidin and Dietary Iron Absorption Following Military-relevant Exercise in Energy Deficit: Pilot Study
Iron Absorption
Recruiting
Dietary Iron Requirements
Iron Absorption
Not yet recruiting
Impact of a Cricket and Black Soldier Fly Larvae-Fortified Cracker on the Gut Microbiome and Iron Status in Malagasy Schoolchildren
Gut -Microbiota, Inflamation
Recruiting
Zinc and Iron Absorption From Common Beans in Young Adult Women
Zinc Absorption, Iron Absorption
Recruiting
Determination of Iron Absorption and Losses in People Living at High Altitude to Investigate the Requirements in This Population Group Using a Newly Developed Technique
Iron Absorption, Iron Requirements
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 Eisensulfat LOMAPHARM 50 mg, Ferinject(R) and iron fortified biscuits in people with Iron Absorption, run by Prof. Michael B. Zimmermann 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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 9 Oct 2018. 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?
Results are not available in the source record.
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 isotope composition in blood (time frame: 9 months). 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 NCT02979132, 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 9 Oct 2018; AzTrials last refreshed its copy on 31 Oct 2026.