Iron Substitution in Blood Donors (ISUB)

This study has been completed.
Sponsor:
Collaborators:
Blutspendedienst SRK Bern AG, 3008 Bern, Switzerland
University of Bern
Kompetenzbereich für Psychosomatische Medizin, Inselspital Bern, Switzerland
Humanitäre Stiftung des Schweizerischen Roten Kreuzes, 3011 Bern, Switzerland
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01519830
First received: January 16, 2012
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Fatigue
Drug: Iron carboxymaltose (Ferinject)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Significance of Iron Deficiency in Transfusion Medicine: Effects of Iron Substitution on Fatigue Und General Well Being in Healthy Blood Donors

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Difference of fatigue on a 10 point numeric scale after intravenous substitution of iron or placebo [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    measured by questionnaire


Secondary Outcome Measures:
  • Change of fatigue after intravenous substitution of iron [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    measured by questionnaire

  • Improvement of general wellbeing [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    measured by questionnaire

  • Number of patients with adverse events of different grades [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 405
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verum
Iron Carboxymaltose (Ferinject)
Drug: Iron carboxymaltose (Ferinject)
Intravenous iron
Placebo Comparator: Placebo
0.9% NaCl solution
Drug: Placebo
0.9% NaCl solution

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

  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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519830

Locations
Switzerland
Department of Hematology, Bern University Hospital
Bern, Switzerland, CH-3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Blutspendedienst SRK Bern AG, 3008 Bern, Switzerland
University of Bern
Kompetenzbereich für Psychosomatische Medizin, Inselspital Bern, Switzerland
Humanitäre Stiftung des Schweizerischen Roten Kreuzes, 3011 Bern, Switzerland
Investigators
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
  More Information

No publications provided

Responsible Party: Peter Keller, MD, Universitätklinik für Hämatologie, Inselspital Bern, CH-3010 Bern
ClinicalTrials.gov Identifier: NCT01519830     History of Changes
Other Study ID Numbers: 010/11, Swissmedic 2011DR3145
Study First Received: January 16, 2012
Last Updated: February 27, 2013
Health Authority: Switzerland: Independent Local Research Ethic Commission (Ethikkommission)
Switzerland: Swiss Agency for therapeutic products (Swissmedic)

Keywords provided by University Hospital Inselspital, Berne:
Anemia, Iron-Deficiency
Blood Donors

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Iron
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014