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Iron Substitution in Blood Donors (ISUB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01519830
First Posted: January 27, 2012
Last Update Posted: February 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Blutspendedienst SRK Bern AG, 3008 Bern, Switzerland
University of Bern
Humanitäre Stiftung des Schweizerischen Roten Kreuzes, 3011 Bern, Switzerland
Information provided by:
University Hospital Inselspital, Berne
January 16, 2012
January 27, 2012
February 28, 2013
January 2012
January 2013   (Final data collection date for primary outcome measure)
Difference of fatigue on a 10 point numeric scale after intravenous substitution of iron or placebo [ Time Frame: 6 weeks ]
measured by questionnaire
Same as current
Complete list of historical versions of study NCT01519830 on ClinicalTrials.gov Archive Site
  • Change of fatigue after intravenous substitution of iron [ Time Frame: 6 weeks ]
    measured by questionnaire
  • Improvement of general wellbeing [ Time Frame: 6 weeks ]
    measured by questionnaire
  • Number of patients with adverse events of different grades [ Time Frame: 6 weeks ]
Same as current
Not Provided
Not Provided
 
Iron Substitution in Blood Donors
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.

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

  1. Assessment of severity of iron deficiency in a large group of blood donors.
  2. Demonstration of an improvement of fatigue after substitution of iron compared with placebo in iron deficient blood donors
  3. Detection of improved general wellbeing in otherwise healthy blood donors after substitution of intravenous iron
  4. 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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fatigue
  • Drug: Iron carboxymaltose (Ferinject)
    Intravenous iron
  • Drug: Placebo
    0.9% NaCl solution
  • Experimental: Verum
    Iron Carboxymaltose (Ferinject)
    Intervention: Drug: Iron carboxymaltose (Ferinject)
  • Placebo Comparator: Placebo
    0.9% NaCl solution
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
405
January 2013
January 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Serum-Ferritin 50 microg/l
  • Eligibility for blood donation
  • At least one prior blood donation

Exclusion Criteria

  • Anemia
  • Known intolerability of intravenous iron
  • History of anaphylactic reactions
  • Active systemic infections
  • Signs of chronic bleeding
  • Known iron overload
  • Lactation
  • Pregnancy
  • Any disease associated with increased fatigue
  • Medication associated with increased fatigue
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01519830
010/11
Swissmedic 2011DR3145
No
Not Provided
Not Provided
Peter Keller, MD, Universitätklinik für Hämatologie, Inselspital Bern, CH-3010 Bern
University Hospital Inselspital, Berne
  • Blutspendedienst SRK Bern AG, 3008 Bern, Switzerland
  • University of Bern
  • Humanitäre Stiftung des Schweizerischen Roten Kreuzes, 3011 Bern, Switzerland
Study Chair: Peter Keller, MD Department of Hematology, Bern University Hospital, Switzerland
Study Chair: Bernhard Lämmle, MD, Prof. Department of Hematology, Bern University Hospital, Switzerland
Study Chair: Stefano Fontana, MD Blutspendedienst SRK Bern AG, Bern, Switzerland
Study Chair: Peter Jüni, MD, Prof. Institut für Sozial- und Präventivmedizin, Universität Bern, Switzerland
Study Chair: Roland von Känel, MD, Prof. Kompetenzbereich für Psychosomatische Medizin, University Hospital Bern
University Hospital Inselspital, Berne
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP