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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Iron Supplementation | Active Comparator | Eisensulfat LOMAPHARM 50 mg administration for 90 days |
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| Intravenous Iron Supplementation | Active Comparator | Single-dose Ferinject(R) administration |
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| Food Fortification with Iron | Active Comparator | Consumption of iron-fortified biscuits (15 mg Fe in form of FeSO4) for 90 d |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eisensulfat LOMAPHARM 50 mg | Drug | oral intake of an 'Eisensulfat LOMAPHARM 50 mg' tablet every morning for 90 days |
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| Measure | Description | Time Frame |
|---|---|---|
| iron isotope composition in blood | tracer to tracee rate in venous blood samples at different time points | 9 months |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Nutrition Laboratory, ETH Zürich | Zurich | Canton of Zurich | 8092 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33693464 | Derived | 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. |
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| Ferinject(R) | Drug | Single-dose Ferinject(R) administration |
|
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| iron fortified biscuits | Dietary Supplement | consumption of an iron-fortfied biscuit every morning for 90 days |
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