Preoperative Supplementation of Sucrosomal Iron as Hematopoietic Support.

Anemia, Iron-Deficiency Clinical Trial

— Preop Iron  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04351607
• Other study ID #: 2020001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: April 2020
• Source: Mein Hanusch-Krankenhaus
• Contact: Alexander Loeckinger, M.D.
• Phone: +43191021
• Email: alexander.loeckinger[@]oegk.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency

Intervention

Dietary Supplement:
• Oleovital® Eisen Forte
60 mg daily oral Supplementation for 3 to 6 weeks

Locations

Country	Name	City	State
Austria	Department of Anestesiology and Critical Care Medicine	Vienna	Penzing

Sponsors (1)

Lead Sponsor	Collaborator
Mein Hanusch-Krankenhaus

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin	1 g/dl increase	3 - 6 weeks