NCT04351607

Preoperative Supplementation of Sucrosomal Iron as Hematopoietic Support.

Einfluss Eines Oralen Eisenpräparats Mit Hoher Bioverfügbarkeit (OLEOvital® EISEN FORTE) Auf Die präoperative Hämoglobinkonzentration Bei anämischen Patienten

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Mein Hanusch-Krankenhaus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: * Group V = Verumgroup with iron supplementation by Oleovital® Eisen Forte * Group K = Control group without iron supplementation - This group receives the usual treatment in the hospital. Furthermore, stratification is carried out according to the sub-collectives * "Patients without menstrual bleeding" (subcollective A) and * "Patients with menstrual bleeding" (subcollective B)

Conditions

• Anemia, Iron-Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oleovital® Eisen Forte	60 mg daily oral Supplementation for 3 to 6 weeks

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-10-01
• Completion: 2022-10-01
• First posted: 2020-04-17
• Last updated: 2020-04-17

Locations

1 site across 1 country: Austria