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The goal of this clinical trial is to evaluate, if a change in dosing strategy in oral iron supplementation from leads to an improvement of iron absorption and consequently a faster therapy in patients with iron deficiency.
The main question the study aims to answer is: Does a treatment effect (measured by change in hemoglobin after 12 weeks of treatment) exist between daily oral iron supplementation and interval administration (every second day)? Participants will receive oral iron supplementation every second day with double the standard dose (intervention group). Researchers will compare this group with the active control group, that receives oral iron supplementation every day with the standard dose.
Participants will present for three patient visits (at baseline, after 6 and after 12 weeks of treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Oral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every second day 2 x 80 mg Tardyferon® for a duration of 12 weeks. |
|
| Active Control | Active Comparator | Oral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every day 1x 80 mg Tardyferon® for a duration of 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tardyferon | Drug | Interval Dosing Strategy (Administration of oral iron every second day with double the standard dose instead of every day standard dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Hemoglobin after 12 weeks | Change (from baseline before treatment) of hemoglobin after 12 weeks of oral iron supplementation | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving treatment goal | Proportion of participants achieving either increase of hemoglobin (>20 g/l), normalization of hemoglobin (women >120 g/l, pregnant women >110 g/l and men >130 g/l) after 12 weeks of oral iron supplementation | 12 weeks |
| Change of iron parameters from baseline |
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Inclusion Criteria:
Exclusion Criteria:
Note
Due to slow recruitment, the following inclusion criterion was removed on 09/25/2024 (MM/DD/YYYY):
Anemia (as defined by the WHO): Hemoglobin <130 g/L for men, Hemoglobin <120 g/l for women, Hemoglobin <110 g/l for pregnant women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luzerner Kantonsspital | Lucerne | Switzerland |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000747 | Anemia, Hypochromic |
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| ID | Term |
|---|---|
| C009380 | ferrous sulfate, mucin drug combination |
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Change of iron parameters from baseline compared to after treatment of 12 weeks |
| 12 weeks |
| Side effects | Side effects during treatment with oral iron supplementation in both groups (intervention and active control) | 12 weeks |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |