FatiguePhase 4ISUBNCT01519830
Iron Substitution in Blood Donors
A Phase 4 study testing Iron carboxymaltose (Ferinject) in people with Fatigue, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Depletion of iron stores is frequently observed in regular blood donors, but effects of iron deficiency on general health is not well studied. Recent studies in women suffering of fatigue suggest iron deficiency without concomitant anemia as a common cause of these complaints. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fatigue
- What is being tested?
- Iron carboxymaltose (Ferinject)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 405 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Jan 2013
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serum-Ferritin 50 microg/l
- Eligibility for blood donation
- At least one prior blood donation
Who cannot join
- Anemia
- Known intolerability of intravenous iron
- History of anaphylactic reactions
- Active systemic infections
- Signs of chronic bleeding
- Known iron overload
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- Lactation
- Pregnancy
- Any disease associated with increased fatigue
- Medication associated with increased fatigue
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Hematology, Bern University Hospital
Bern, Canton of Bern, CH-3010
About this study
Official title: Significance of Iron Deficiency in Transfusion Medicine: Effects of Iron Substitution on Fatigue Und General Well Being in Healthy Blood Donors
Depletion of iron stores is frequently observed in regular blood donors, but effects of iron deficiency on general health is not well studied. Recent studies in women suffering of fatigue suggest iron deficiency without concomitant anemia as a common cause of these complaints. Provided the same is true in healthy subjects, substitution of intravenous iron might result in an improvement of general well being in iron depleted blood donors.
Healthy regular blood donors will be screened for low storage iron. Qualifying subjects will be invited to participate in a randomized, placebo-controlled trial with substitution of intravenous iron or placebo (saline solution). Differences in subjectively felt fatigue and other factors of general health and well being will be assessed. If an improvement of such factors can be shown after iron replacement, relevant concerns about artificially lowering iron stores by repeated phlebotomies will arise and changes of monitoring and substitution policies in blood banking might have to be discussed.
Read the detailed description
Background
Chronic iron deficiency causes anemia with impairment of physical and mental capacity. Since iron plays an essential role in many enzymes apart from oxygen carriage, iron deficiency was proposed as an independent factor impairing wellbeing also without anemia. Symptoms like fatigue, asthenia, physical weakness, mental impairment and many others have been associated with iron deficiency. Recent clinical trials with iron substitution in iron deficient women suffering of general fatigue support this hypothesis, but data are still conflicting and debated.
Low body iron stores are frequently observed in blood donors. Repeated phlebotomies may induce or aggravate severe iron deficiency. Astonishingly, little is known about the long term effects of reduced iron stores on general health of regular blood donors. Serious health impairment cannot be excluded conclusively. Since many symptoms associated with iron deficiency are subtle, they might be missed by otherwise healthy subjects.
Blood donors with borderline or decreased iron stores (i.e. serum ferritin below 50 microg/l) will be invited to participate in a randomized, placebo-controlled intervention study comparing intravenous iron carboxymaltose and a physiological saline solution (placebo). Subjectively felt fatigue, measured on a numeric rating scale from 1 to 10 as the major end point will be assessed before and six months after application of the study drug. As additional factors, various aspects of general wellbeing will be assessed using four psychometric questionnaires. Statistical analysis will compare the results before and after application of the study drug and the results of the two study arms.
Objective
- Assessment of severity of iron deficiency in a large group of blood donors.
- Demonstration of an improvement of fatigue after substitution of iron compared with placebo in iron deficient blood donors
- Detection of improved general wellbeing in otherwise healthy blood donors after substitution of intravenous iron
- Assessment of tolerability of intravenous iron in healthy blood donors
Methods
Randomized, placebo controlled interventional trial comparing the effect of intravenous iron or placebo on fatigue and various other factors of general wellbeing. Endpoints assessed on a numeric rating scale from 1 to 10 and four psychometric questionnaires.
- Conditions
- Fatigue
- Being tested
- Iron carboxymaltose (Ferinject), Placebo
- Keywords
- Anemia, Iron-Deficiency, Blood Donors
- Medical subject headings
- Fatigue, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron carboxymaltose (Ferinject)Drug
Intravenous iron
PlaceboDrug
0.9% NaCl solution
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Iron Carboxymaltose (Ferinject) Receives: Drug: Iron carboxymaltose (Ferinject) |
| Placebo | Placebo comparator | 0.9% NaCl solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of fatigue on a 10 point numeric scale after intravenous substitution of iron or placebo
measured by questionnaire
Measured: 6 weeks
Secondary outcomes (3)
Change of fatigue after intravenous substitution of iron
measured by questionnaire
Measured: 6 weeks
Improvement of general wellbeing
measured by questionnaire
Measured: 6 weeks
Number of patients with adverse events of different grades
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Blutspendedienst SRK Bern AG, 3008 Bern, Switzerland, University of Bern, Humanitäre Stiftung des Schweizerischen Roten Kreuzes, 3011 Bern, Switzerland
- Investigators
- Peter Keller, MD, Study chair, Department of Hematology, Bern University Hospital, SwitzerlandBernhard Lämmle, MD, Prof., Study chair, Department of Hematology, Bern University Hospital, SwitzerlandStefano Fontana, MD, Study chair, Blutspendedienst SRK Bern AG, Bern, SwitzerlandPeter Jüni, MD, Prof., Study chair, Institut für Sozial- und Präventivmedizin, Universität Bern, SwitzerlandRoland von Känel, MD, Prof., Study chair, Kompetenzbereich für Psychosomatische Medizin, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519830
- Sponsor's protocol ID
- 010/11
- Other IDs
- Swissmedic 2011DR3145
- Acronym
- ISUB
- Status last verified
- Feb 2013
- First submitted
- 16 Jan 2012
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Iron Deficiency in Transfusion Medicine: Effects of Iron Substitution on Fatigue Und General Well Being in Healthy Blood Donors
- ClinicalTrials.gov ID
- NCT01519830
- Acronym / sponsor ID
- ISUB / 010/11
- Conditions
- Fatigue
- Keywords
- Anemia, Iron-Deficiency, Blood Donors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Blutspendedienst SRK Bern AG, 3008 Bern, Switzerland, University of Bern, Humanitäre Stiftung des Schweizerischen Roten Kreuzes, 3011 Bern, Switzerland
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 27 Jan 2012 (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.
Depletion of iron stores is frequently observed in regular blood donors, but effects of iron deficiency on general health is not well studied. Recent studies in women suffering of fatigue suggest iron deficiency without concomitant anemia as a common cause of these complaints. Provided the same is true in healthy subjects, substitution of intravenous iron might result in an improvement of general well being in iron depleted blood donors.
Healthy regular blood donors will be screened for low storage iron. Qualifying subjects will be invited to participate in a randomized, placebo-controlled trial with substitution of intravenous iron or placebo (saline solution). Differences in subjectively felt fatigue and other factors of general health and well being will be assessed. If an improvement of such factors can be shown after iron replacement, relevant concerns about artificially lowering iron stores by repeated phlebotomies will arise and changes of monitoring and substitution policies in blood banking might have to be discussed.
Detailed description
Background
Chronic iron deficiency causes anemia with impairment of physical and mental capacity. Since iron plays an essential role in many enzymes apart from oxygen carriage, iron deficiency was proposed as an independent factor impairing wellbeing also without anemia. Symptoms like fatigue, asthenia, physical weakness, mental impairment and many others have been associated with iron deficiency. Recent clinical trials with iron substitution in iron deficient women suffering of general fatigue support this hypothesis, but data are still conflicting and debated.
Low body iron stores are frequently observed in blood donors. Repeated phlebotomies may induce or aggravate severe iron deficiency. Astonishingly, little is known about the long term effects of reduced iron stores on general health of regular blood donors. Serious health impairment cannot be excluded conclusively. Since many symptoms associated with iron deficiency are subtle, they might be missed by otherwise healthy subjects.
Blood donors with borderline or decreased iron stores (i.e. serum ferritin below 50 microg/l) will be invited to participate in a randomized, placebo-controlled intervention study comparing intravenous iron carboxymaltose and a physiological saline solution (placebo). Subjectively felt fatigue, measured on a numeric rating scale from 1 to 10 as the major end point will be assessed before and six months after application of the study drug. As additional factors, various aspects of general wellbeing will be assessed using four psychometric questionnaires. Statistical analysis will compare the results before and after application of the study drug and the results of the two study arms.
Objective
- Assessment of severity of iron deficiency in a large group of blood donors.
- Demonstration of an improvement of fatigue after substitution of iron compared with placebo in iron deficient blood donors
- Detection of improved general wellbeing in otherwise healthy blood donors after substitution of intravenous iron
- Assessment of tolerability of intravenous iron in healthy blood donors
Methods
Randomized, placebo controlled interventional trial comparing the effect of intravenous iron or placebo on fatigue and various other factors of general wellbeing. Endpoints assessed on a numeric rating scale from 1 to 10 and four psychometric questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Drug: Iron carboxymaltose (Ferinject)Iron Carboxymaltose (Ferinject) |
| Placebo | Placebo comparator | Drug: Placebo0.9% NaCl solution |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Serum-Ferritin 50 microg/l
- Eligibility for blood donation
- At least one prior blood donation
Key exclusion criteria (10 listed)
- Anemia
- Known intolerability of intravenous iron
- History of anaphylactic reactions
- Active systemic infections
- Signs of chronic bleeding
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 |
|---|---|---|
| Iron carboxymaltose (Ferinject)Intravenous iron | Drug | Verum |
| Placebo0.9% NaCl solution | Drug | Placebo |
Primary outcome
Difference of fatigue on a 10 point numeric scale after intravenous substitution of iron or placebo
Time frame: 6 weeks
measured by questionnaire
3 secondary outcomes
Change of fatigue after intravenous substitution of iron
Time frame: 6 weeks
Improvement of general wellbeing
Time frame: 6 weeks
Number of patients with adverse events of different grades
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2013.
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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.
Peter Keller, MD study chair
Department of Hematology, Bern University Hospital, Switzerland
Bernhard Lämmle, MD, Prof. study chair
Department of Hematology, Bern University Hospital, Switzerland
Stefano Fontana, MD study chair
Blutspendedienst SRK Bern AG, Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron carboxymaltose (Ferinject) in people with Fatigue, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 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: finished, as of the sponsor's last update on 28 Feb 2013. 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 Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference of fatigue on a 10 point numeric scale after intravenous substitution of iron or placebo (time frame: 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 28 Feb 2013.