Clinical trial NCT04351607: Preoperative Supplementation of Sucrosomal Iron as Hematopoietic Support.
Official title: Einfluss Eines Oralen Eisenpräparats Mit Hoher Bioverfügbarkeit (OLEOvital® EISEN FORTE) Auf Die präoperative Hämoglobinkonzentration Bei anämischen Patienten
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anemia, Iron-Deficiency
Lead sponsor: Mein Hanusch-Krankenhaus
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Eligibility criteria: Inclusion Criteria:

* Written consent according to previous written and oral clarification
* Elective intervention in 3-6 weeks
* Hemoglobin (Hb) -12.0g/dl
* Age \>18 years
* Non-cardiac surgery

Exclusion Criteria:

* Non-business capability or legal representation
* Pregnancy
* Breastfeeding period
* Chronic diarrhoea (\> 4 weeks)
* Known massive absorption restriction (e.g. short bowel syndrome)
* Known or suspected fructose intolerance
* Iron accumulation disorders: hemochromatosis, hemosiderosis
* Vegan diet
* Use of a preparation to specifically increase the body's own erythrocyte or hemoglobin concentration or production (e.g. EPO preparations, erythrocyte concentrates) in the last 4 weeks
* Permanent or preoperativeblood loss (e.g. seepage bleeding)
* Intended intake/application of another iron-supplementing preparation before surgery
* Intended use of preparations to specifically increase the body's own erythrocyte or hemoglobin concentration or production (e.g. EPO preparations, erythrocyte concentrates) prior to surgery
* Simultaneous participation in another clinical trial with insurance cover
* Foreseeable compliance issues
* Existing refractory disorder of the bone marrow: myelodysplasia
* In the case of conspicuous base laboratory towards undiagnosed hemochromatosis: increased plasma iron, increased serum ferritin and increased transferrin saturation without increased signs of inflammation (CRP), the patient is assigned to the hematological department of the Hanusch Hospital for further diagnosis.
* Acutely therapeutic anemia Hb x 8 g/dl (indication for a mandatory correction of the Hb to a clinically safe or non-therapeutic value - no randomization into the control group makes sense)

Primary outcomes:
measure: hemoglobin
timeFrame: 3 - 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Anestesiology and Critical Care Medicine
state: Penzing
Study officials:
References: