An interventional study of Eisensulfat LOMAPHARM 50 mg and Ferinject(R) in Iron Absorption, sponsored by Prof. Michael B. Zimmermann. Status unknown at 1 site in Switzerland. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by Prof. Michael B. Zimmermann · Not applicable, Interventional, and Diagnostic
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.
Prof. Michael B. Zimmermann is the lead sponsor of 5 studies on the registry; none are open to participants now.
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The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eisensulfat LOMAPHARM 50 mg administration for 90 days
Drug: Eisensulfat LOMAPHARM 50 mg
Single-dose Ferinject(R) administration
Drug: Ferinject(R)
Consumption of iron-fortified biscuits (15 mg Fe in form of FeSO4) for 90 d
Dietary Supplement: iron fortified biscuits
oral intake of an 'Eisensulfat LOMAPHARM 50 mg' tablet every morning for 90 days
Also known as: Eisentabletten
Single-dose Ferinject(R) administration
Also known as: Iron Infusion
consumption of an iron-fortfied biscuit every morning for 90 days
Also known as: HUG-Biskuits
iron isotope composition in blood
tracer to tracee rate in venous blood samples at different time points
Time frame: 9 months
Plan to share: Undecided
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ferric carboxymaltose
Prof. Michael B. Zimmermann