Fatigue Clinical Trial
Official 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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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