Iron Substitution in Blood Donors
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Iron carboxymaltose (Ferinject); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous iron; 0.9% NaCl solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anemia, Iron-Deficiency; Blood Donors