Iron Substitution in Blood Donors

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

• Assessment of severity of iron deficiency in a large group of blood donors.
• Demonstration of an improvement of fatigue after substitution of iron compared with placebo in iron deficient blood donors
• Detection of improved general wellbeing in otherwise healthy blood donors after substitution of intravenous iron
• 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.

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