Iron Substitution in Blood Donors

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborators: Blutspendedienst SRK Bern AG, 3008 Bern, Switzerland; Humanitäre Stiftung des Schweizerischen Roten Kreuzes, 3011 Bern, Switzerland; University of Bern
• Treatments: Ferric Compounds; Iron

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