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Effect of intravenous iron substitution (iron carboxymaltose (Ferinject®), total dose 15 mg/ kg (maximal dose: 1000mg) in 250 ml 0.9 % NaCl; intravenous infusion in 20 min)in non-anemic premenopausal women with iron deficiency on
Primary objective:
- Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of the lower leg muscle)
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravenous iron carboxymaltose | Experimental | intravenous iron carboxymaltose infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous iron carboxymaltose | Drug | The patients will be randomized to one of the 2 treatment groups (12 patients in each group): Group I: intravenous iron carboxymaltose; Group II: intravenous placebo. Group I (intravenous iron): Ferinject will be applied via a short infusion. Patients will receive 15mg/kg of iron as iron carboxymaltose Ferinject® in 250 ml 0.9% NaCl intravenously (time of infusion 20 mins), in a single dose. The maximum dose is limited to 1000mg iron. Group II (intravenous placebo): Intravenous placebo (250 ml 0.9 % NaCl will be administrated in the same manner and time schedule than group I. |
| Measure | Description | Time Frame |
|---|---|---|
| Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of the lower leg muscle) | one year |
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Inclusion criteria: INCLUSION CRITERIA
Exclusion criteria: EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-Alexandre Krayenbuehl, MD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Clinic and Policlinic of Internal Medicine | Zurich | Canton of Zurich | 8091 | Switzerland |
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