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| ID | Type | Description | Link |
|---|---|---|---|
| KEK-ZH-Nr. 2014-0217 | Other Identifier | KEK Zurich |
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This study investigates the effect of intravenous iron substitution in non-anaemic premenopausal women with iron deficiency on:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm 1 | Experimental | Patients will be treated with 0.9% sodium chloride (placebo) at Visit 1 and with iron carboxymaltose in 6 weeks at Visit 2. The patients will be blinded with respect to the treatment sequence. |
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| Treatment Arm 2 | Experimental | Patients will be treated with 0.9% sodium chloride (placebo) at Visit 1 and with iron carboxymaltose in 6 weeks at Visit 2. The patients will be blinded with respect to the treatment sequence. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Carboxymaltose | Drug | Single intravenous infusion within 20 min |
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| Measure | Description | Time Frame |
|---|---|---|
| Dopamine (DA) receptor density | Changes in the cerebral Dopamine (DA) receptor density determined by brain PET with the 11C-Raclopride tracer | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue | Reduction of fatigue after iron supplementation determined by Fatigue Assessment Scale (FAS) | 6 weeks |
| Fatigue | Reduction of fatigue after iron supplementation determined by "Würzburger Erschöpfungs-Inventar bei Multipler Sklerose" (WEIMuS, in German) questionaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Albina Nowak, MD | Contact | +41 (0)44 255 10 54 | albina.nowak@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Albina Nowak, MD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Zurich | Switzerland |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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The patients will be blinded with respect to the treatment sequence. The outcome assessor (PET scan evaluator) will be blinded with respect to the participant identity and the date of the PET scan.
| Sodium chloride 0.9% | Drug | Single intravenous infusion of 250 ml within 20 min |
|
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| 6 weeks |
| Neuropsychological symptoms | Reduction of neuropsychological symptoms after iron supplementation determined by neuropsychological assessment | 6 weeks |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017670 |
| Sodium Compounds |