Fatigue Clinical Trial
— ISUBOfficial 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.
Status | Completed |
Enrollment | 405 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Hematology, Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | Blutspendedienst SRK Bern AG, 3008 Bern, Switzerland, Humanitäre Stiftung des Schweizerischen Roten Kreuzes, 3011 Bern, Switzerland, University of Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference of fatigue on a 10 point numeric scale after intravenous substitution of iron or placebo | measured by questionnaire | 6 weeks | No |
Secondary | Change of fatigue after intravenous substitution of iron | measured by questionnaire | 6 weeks | No |
Secondary | Improvement of general wellbeing | measured by questionnaire | 6 weeks | No |
Secondary | Number of patients with adverse events of different grades | 6 weeks | Yes |
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