Iron Deficiency AnemiaNCT02973074
Oral Iron Substitution for Orthopedic Surgery
A study testing OLEOvital in people with Iron Deficiency Anemia, run by Kepler University Hospital at 1 site in Austria.
Trial summary
The aim of this pilot study is to investigate an 4 weeks period of oral iron substitution in the course of Patient Blood Management in preparation for orthopedic surgery. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- OLEOvital
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 25 Nov 2016to 1 Nov 2017
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 55 years
- indication for patient blood management for elective orthopedic surgery
- listed for a orthopedic surgery (e.g. hip or knee replacement) 5-7 weeks after begin of patient blood management
- Haemoglobin male < 12-13g/dl, female <11-12g/dl
- written informed consent after written and verbal information
Who cannot join
- indication for treatment with erythropoietin
- pregnancy
- nursing period
- diarrhea or tendency to diarrhea
- fructose intolerance
- pre - menopause
Show all 10Show fewer
- permanent or expected blood loss
- participation in other study
- expected compliance problems
- legal incapacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study for Investigation of the Feasibility and for Optimization of Oral Iron Substitution in the Course of Patient Blood Management for Orthopedic Surgery
The aim of this pilot study is to investigate an 4 weeks period of oral iron substitution in the course of Patient Blood Management in preparation for orthopedic surgery.
Read the detailed description
Patient blood management (PBM) is a clinical multidisciplinary, patient orientated concept for treatment of anaemia, reduction of intraoperative blood loss and increasing anaemic tolerance.
In the Kepler University Hospital (former General Hospital Linz) PBM was introduced in 2006. Since then patients for elective orthopedic surgery (knee an hip replacement) are screened for iron deficiency anaemia and if needed treated with the more effective intravenous iron.
Oral iron medications are not as efficient (low bioavailability, more side effects) as the intravenous iron infusion. Although there is risk of anaphylactoid reactions.
In this study the new oral iron supplement OLEOvital Eisen forte (available in Austria) ist tested on its effectivity for treatment of iron deficiency in the course of PBM.
It has a much more higher bioavailability without the typically side effects of the routinely used oral iron medications.
Within this study the investigators want to examine the feasibility of this iron substitution concept OLEOvital and its efficacy. Also the investigators want to get pilot data for a further randomized controlled trial.
The increase of the hemoglobin level in 4 weeks of minimum 1g/dl is going to be expected and monitored.
For comparison of the new oral substitution concept OLEOvital with the standard intravenous iron substitution an historic control group is going to be used.
- Conditions
- Iron Deficiency Anemia
- Being tested
- OLEOvital
- Keywords
- iron deficiency, patient blood management, anemia
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLEOvitalDietary supplement
2sachets with 30mg iron per day for a 4 weeks period
| Study group | Role | What they receive |
|---|---|---|
| OLEOvital | Other | 30mg iron are being administered orally twice a day for a period of 4 Weeks it is a granulated powder which is taken orally and then solved with saliva, without taking water Receives: Dietary Supplement: OLEOvital |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase of hemoglobin level
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study start25 Nov 2016
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Why it stopped: no enough partícipants enrolled in the 1 year planned for recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Pauker, MD, Kepler University Hospital
- Investigators
- Jens Meier, Prof. Dr., Principal investigator, Kepler University Hospital Linz, Clinic for Anesthesiology and intensive care medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973074
- Sponsor's protocol ID
- C-124-16
- Status last verified
- Aug 2018
- First submitted
- 22 Nov 2016
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gombotz H, Rehak PH, Shander A, Hofmann A. Blood use in elective surgery: the Austrian benchmark study. Transfusion. 2007 Aug;47(8):1468-80. doi: 10.1111/j.1537-2995.2007.01286.x.
PubMed 17655591Seicean A, Alan N, Seicean S, Neuhauser D, Weil RJ. The effect of blood transfusion on short-term, perioperative outcomes in elective spine surgery. J Clin Neurosci. 2014 Sep;21(9):1579-85. doi: 10.1016/j.jocn.2014.03.003. Epub 2014 May 19.
PubMed 24852902Danninger T, Rasul R, Poeran J, Stundner O, Mazumdar M, Fleischut PM, Poultsides L, Memtsoudis SG. Blood transfusions in total hip and knee arthroplasty: an analysis of outcomes. ScientificWorldJournal. 2014 Jan 21;2014:623460. doi: 10.1155/2014/623460. eCollection 2014.
PubMed 24587736Meybohm P, Richards T, Isbister J, Hofmann A, Shander A, Goodnough LT, Munoz M, Gombotz H, Weber CF, Choorapoikayil S, Spahn DR, Zacharowski K. Patient Blood Management Bundles to Facilitate Implementation. Transfus Med Rev. 2017 Jan;31(1):62-71. doi: 10.1016/j.tmrv.2016.05.012. Epub 2016 May 28.
PubMed 27317382
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Investigation of the Feasibility and for Optimization of Oral Iron Substitution in the Course of Patient Blood Management for Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT02973074
- Acronym / sponsor ID
- C-124-16
- Conditions
- Iron Deficiency Anemia
- Keywords
- iron deficiency, patient blood management, anemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no enough partícipants enrolled in the 1 year planned for recruitment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Study start
- 25 Nov 2016
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 25 Nov 2016 (estimated)
- 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.
The aim of this pilot study is to investigate an 4 weeks period of oral iron substitution in the course of Patient Blood Management in preparation for orthopedic surgery.
Detailed description
Patient blood management (PBM) is a clinical multidisciplinary, patient orientated concept for treatment of anaemia, reduction of intraoperative blood loss and increasing anaemic tolerance.
In the Kepler University Hospital (former General Hospital Linz) PBM was introduced in 2006. Since then patients for elective orthopedic surgery (knee an hip replacement) are screened for iron deficiency anaemia and if needed treated with the more effective intravenous iron.
Oral iron medications are not as efficient (low bioavailability, more side effects) as the intravenous iron infusion. Although there is risk of anaphylactoid reactions.
In this study the new oral iron supplement OLEOvital Eisen forte (available in Austria) ist tested on its effectivity for treatment of iron deficiency in the course of PBM.
It has a much more higher bioavailability without the typically side effects of the routinely used oral iron medications.
Within this study the investigators want to examine the feasibility of this iron substitution concept OLEOvital and its efficacy. Also the investigators want to get pilot data for a further randomized controlled trial.
The increase of the hemoglobin level in 4 weeks of minimum 1g/dl is going to be expected and monitored.
For comparison of the new oral substitution concept OLEOvital with the standard intravenous iron substitution an historic control group is going to be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OLEOvital | Other | Dietary Supplement: OLEOvital30mg iron are being administered orally twice a day for a period of 4 Weeks it is a granulated powder which is taken orally and then solved with saliva, without taking water |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age over 55 years
- indication for patient blood management for elective orthopedic surgery
- listed for a orthopedic surgery (e.g. hip or knee replacement) 5-7 weeks after begin of patient blood management
- Haemoglobin male < 12-13g/dl, female <11-12g/dl
- written informed consent after written and verbal information
Key exclusion criteria (10 listed)
- indication for treatment with erythropoietin
- pregnancy
- nursing period
- diarrhea or tendency to diarrhea
- fructose intolerance
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 |
|---|---|---|
| OLEOvital2sachets with 30mg iron per day for a 4 weeks period | Dietary supplement | OLEOvital |
Primary outcome
increase of hemoglobin level
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: no enough partícipants enrolled in the 1 year planned for recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Background: PubMed 17655591Gombotz H, Rehak PH, Shander A, Hofmann A. Blood use in elective surgery: the Austrian benchmark study. Transfusion. 2007 Aug;47(8):1468-80. doi: 10.1111/j.1537-2995.2007.01286.x.
- Background: PubMed 24852902Seicean A, Alan N, Seicean S, Neuhauser D, Weil RJ. The effect of blood transfusion on short-term, perioperative outcomes in elective spine surgery. J Clin Neurosci. 2014 Sep;21(9):1579-85. doi: 10.1016/j.jocn.2014.03.003. Epub 2014 May 19.
- Background: PubMed 24587736Danninger T, Rasul R, Poeran J, Stundner O, Mazumdar M, Fleischut PM, Poultsides L, Memtsoudis SG. Blood transfusions in total hip and knee arthroplasty: an analysis of outcomes. ScientificWorldJournal. 2014 Jan 21;2014:623460. doi: 10.1155/2014/623460. eCollection 2014.
- Background: PubMed 27317382Meybohm P, Richards T, Isbister J, Hofmann A, Shander A, Goodnough LT, Munoz M, Gombotz H, Weber CF, Choorapoikayil S, Spahn DR, Zacharowski K. Patient Blood Management Bundles to Facilitate Implementation. Transfus Med Rev. 2017 Jan;31(1):62-71. doi: 10.1016/j.tmrv.2016.05.012. Epub 2016 May 28.
- Individual participant dataSharing planned: No
Related trials for Iron Deficiency Anemia
Enrolling by invitationObservational study
Long-term Impacts of Psychosocial Stimulation and Iron Supplementation
Iron Deficiency Anemia, Parenting Intervention
Active, not recruiting
Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency
Iron Deficiency (Without Anemia)
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
RecruitingPhase 3
Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Gynecologic Cancer, Anemia
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.
Jens Meier, Prof. Dr. principal investigator
Kepler University Hospital Linz, Clinic for Anesthesiology and intensive care medicine
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 in people with Iron Deficiency Anemia, run by Kepler University Hospital 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 10 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: stopped early, as of the sponsor's last update on 9 Aug 2018. 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?
The study was stopped early (reason given: no enough partícipants enrolled in the 1 year planned for recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increase of hemoglobin level (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02973074, which also lists 4 linked publications.
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 9 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.