Abstract

Background: Besides anemia, iron deficiency may cause more subtle symptoms, including the restless legs syndrome (RLS), the chronic fatigue syndrome (CFS) or sleeping disorders. Objective: The aim of this pre-planned secondary analysis of the IronWoMan randomized controlled trial (RCT) was to compare the frequency and severity of symptoms associated with iron deficiency before and after (intravenous or oral) iron supplementation in iron deficient blood donors. Methods/Design: Prospective, randomized, controlled, single-centre trial. (ClinicalTrials.gov: NCT01787526). Setting: Tertiary care center in Graz, Austria. Participants: 176 (138 female and 38 male) whole-blood and platelet apheresis donors aged ≥ 18 and ≤ 65 years with iron deficiency (ferritin ≤ 30ng/mL at the time of blood donation). Interventions: Intravenous iron (1 g ferric carboxymaltose, n = 86) or oral iron supplementation (10 g iron fumarate, 100 capsules, n = 90). Measurements: Clinical symptoms were evaluated by a survey before iron therapy (visit 0, V0) and after 8–12 weeks (visit 1, V1), including questions about symptoms of restless legs syndrome (RLS), chronic fatigue syndrome (CFS), sleeping disorders, quality of life and symptoms like headaches, dyspnoea, dizziness, palpitations, pica and trophic changes in fingernails or hair. Results: We found a significant improvement in the severity of symptoms for RLS, fatigue and sleep quality (p < 0.001). Furthermore, a significant decrease in headaches, dyspnoea, dizziness and palpitations was reported (p < 0.05). There was no difference between the type of iron supplementation (intravenous versus oral) and clinical outcome data. Conclusion: Iron supplementation in iron-deficient blood donors may be an effective strategy to improve symptoms related to iron deficiency and the wellbeing of blood donors.

Highlights

  • An imbalance between iron requirements and iron supply results in iron deficiency (ID), the most prevalent nutritive disorder worldwide [1]

  • Between June 2014 and June 2016, a total of 467 blood donors (370 women, 97 men) with a serum ferritin ≤ 30 ng/mL were invited to participate in the study

  • There was no significant difference between subgroups with lower or ferritin levels levels at at visit visit 11. In this pre-planned secondary analysis of the IronWoMan randomized controlled trial (RCT) [32], we aimed to evaluate if clinical symptoms associated with ID improve after iron supplementation

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Summary

Introduction

An imbalance between iron requirements and iron supply results in iron deficiency (ID), the most prevalent nutritive disorder worldwide [1]. Given the maximum number of donations per year (e.g., in Austria 4–6 whole blood donations, and up to 26 platelet or 45 plasma donations), blood donations may substantially compromise the iron store of individual donors who are often iron-deficient [20,21,22,23,24,25,26,27,28,29,30,31]. Iron deficiency may cause more subtle symptoms, including the restless legs syndrome (RLS), the chronic fatigue syndrome (CFS) or sleeping disorders. Objective: The aim of this pre-planned secondary analysis of the IronWoMan randomized controlled trial (RCT) was to compare the frequency and severity of symptoms associated with iron deficiency before and after (intravenous or oral) iron supplementation in iron deficient blood donors.

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