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To prove, if preoperative elective anemic patients improve their hemoglobin levels within 3-6 weeks preoperativly after daily oral dietary supplementation of 60mg sucrosomal iron.
Patients with preoperative anemia have a poorer perioperative outcome in morbidity and mortality as part of surgery. Oral iron preparations have so far had poor bioavailability (approx. 30%) and mostly gastrointestinal side effects that often lead to discontinuation of treatment. Intravenous iron preparations also have an increased risk of allergic disease, which has already led to deaths in Austria. Oleovital® Eisen Forte shows improved bioavailability and hardly any gastrointestinal side effects. It should be improved in anemic patients by oleovital iron forte the hemoglobin content of the blood before surgery. Preoperative anemia is a relatively common problem that has not been preoperatively treated so far and therefore studies such as the one present here are very relevant.
The dietary supplement (Oleovital® Eisen Forte) has been on the market in Austria for iron substitution since autumn 2016. Oleovital® Eisen Forte seems suitable to produce a physiological hemoglobin content. The improved galenics is without previously known gastrointestinal side effects and should be investigated in an oral dose of 2 x 30mg (=60mg) p.o. per day over a limited intake of 3-6 weeks due to increased physiological iron demand.
The main objective of the study following a confirmant approach is to verify whether a sufficiently high number of anemic patients benefit from the oral intake of a high bioavailability iron preparation (Oleovital® Eisen Forte) in the last three to six weeks before an elective intervention (profit = response = increase in hemoglobin concentration by at least 1g/dl).
This controlled, randomized, open, prospective, monocentric study (two-armed parallel group design) should be classified as a food study (application of the commercial dietary supplement Oleovital® Eisen Forte) in an interventional setting - study-specific measures: additional blood tests and intake of Oleovital® Eisen Forte, in certain cases additional for a study-specific blood test are re-quired.
There are two study arms or groups:
Furthermore, stratification is carried out according to the sub-collectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Experimental | oral dose of 2 x 30mg (=60mg) Oleovital® Eisen Forte p.o. per day over a limited intake of 3-6 weeks due to increased physiological iron demand |
|
| Control group | No Intervention | no intervention | |
| Patient with menstral bleeding - subcollective A | Other | verum or control |
|
| Patient without menstral bleeding - subcollective B | Other | verum or control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oleovital® Eisen Forte | Dietary Supplement | 60 mg daily oral Supplementation for 3 to 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| hemoglobin | 1 g/dl increase | 3 - 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
with or without menstral bleeding
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander Loeckinger, M.D. | Contact | +43191021 | 57158 | alexander.loeckinger@oegk.at |
| Engelbert Deusch, M.D. | Contact | +43191021 | 57162 | engelbert.deusch@oegk.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anestesiology and Critical Care Medicine | Recruiting | Vienna | Penzing | 1140 | Austria |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C068637 | calcium D-pantothenate, L-cysteine drug combination |
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|
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |