Anemia, Iron-DeficiencyPreop IronNCT04351607
Preoperative Supplementation of Sucrosomal Iron as Hematopoietic Support.
A study testing Oleovital® Eisen Forte in people with Anemia, Iron-Deficiency, run by Mein Hanusch-Krankenhaus at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Iron-Deficiency
- What is being tested?
- Oleovital® Eisen Forte
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2019to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Anestesiology and Critical Care Medicine
Vienna, Penzing, 1140
Alexander Loeckinger, M.D., +43191021 ext. 57158, alexander.loeckinger@oegk.at
Engelbert Deusch, M.D., +43191021 ext. 57162, engelbert.deusch@oegk.at
About this study
Official title: Einfluss Eines Oralen Eisenpräparats Mit Hoher Bioverfügbarkeit (OLEOvital® EISEN FORTE) Auf Die präoperative Hämoglobinkonzentration Bei anämischen Patienten
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.
Read the 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
- Being tested
- Oleovital® Eisen Forte
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oleovital® Eisen ForteDietary supplement
Also called Verum
60 mg daily oral Supplementation for 3 to 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Oleovital® Eisen Forte |
| Control group | No intervention | no intervention |
| Patient with menstral bleeding - subcollective A | Other | verum or control Receives: Dietary Supplement: Oleovital® Eisen Forte |
| Patient without menstral bleeding - subcollective B | Other | verum or control Receives: Dietary Supplement: Oleovital® Eisen Forte |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin
1 g/dl increase
Measured: 3 - 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Oct 2019
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Iron-DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mein Hanusch-Krankenhaus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Löckinger MD., Msc., Mein Hanusch-Krankenhaus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351607
- Sponsor's protocol ID
- 2020001
- Acronym
- Preop Iron
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Einfluss Eines Oralen Eisenpräparats Mit Hoher Bioverfügbarkeit (OLEOvital® EISEN FORTE) Auf Die präoperative Hämoglobinkonzentration Bei anämischen Patienten
- ClinicalTrials.gov ID
- NCT04351607
- Acronym / sponsor ID
- Preop Iron / 2020001
- Conditions
- Anemia, Iron-Deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mein Hanusch-KrankenhausUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Dietary Supplement: Oleovital® Eisen Forteoral 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 | Dietary Supplement: Oleovital® Eisen Forteverum or control |
| Patient without menstral bleeding - subcollective B | Other | Dietary Supplement: Oleovital® Eisen Forteverum or control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- Non-business capability or legal representation
- Pregnancy
- Breastfeeding period
- Chronic diarrhoea (> 4 weeks)
- Known massive absorption restriction (e.g. short bowel syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oleovital® Eisen ForteAlso: Verum60 mg daily oral Supplementation for 3 to 6 weeks | Dietary supplement | Patient with menstral bleeding - subcollective A, Patient without menstral bleeding - subcollective B, Verum |
Primary outcome
hemoglobin
Time frame: 3 - 6 weeks
1 g/dl increase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oleovital® Eisen Forte in people with Anemia, Iron-Deficiency, run by Mein Hanusch-Krankenhaus at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Loeckinger, M.D. (+43191021 ext. 57158, alexander.loeckinger@oegk.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemoglobin (time frame: 3 - 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.