Iron Substitution in Blood Donors

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. 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.

Conditions

• Fatigue

Interventions

DRUG

Iron carboxymaltose (Ferinject)

Intravenous iron

DRUG

Placebo

0.9% NaCl solution

Sponsors & Collaborators

• Blutspendedienst SRK Bern AG, 3008 Bern, Switzerland

  collaborator UNKNOWN

• University of Bern

  collaborator OTHER

• Humanitäre Stiftung des Schweizerischen Roten Kreuzes, 3011 Bern, Switzerland

  collaborator UNKNOWN

• Insel Gruppe AG, University Hospital Bern

  lead OTHER

Principal Investigators

• Peter Keller, MD · Department of Hematology, Bern University Hospital, Switzerland

• Bernhard Lämmle, MD, Prof. · Department of Hematology, Bern University Hospital, Switzerland

• Stefano Fontana, MD · Blutspendedienst SRK Bern AG, Bern, Switzerland

• Peter Jüni, MD, Prof. · Institut für Sozial- und Präventivmedizin, Universität Bern, Switzerland

• Roland von Känel, MD, Prof. · Kompetenzbereich für Psychosomatische Medizin, University Hospital Bern

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2013-01-31

Completion

2013-01-31

Countries

• Switzerland

Study Locations