The effects of intravenous iron supplementation on fatigue and general health in non-anemic blood donors with iron deficiency: a randomized placebo-controlled superiority trial

Division of Hematology, Department of Internal Medicine, SRO AG Spital Langenthal, Langenthal, Switzerland. Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, University of Zurich, Culmannstrasse 8, 8091, Zurich, Switzerland. roland.vonkaenel@usz.ch. Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada. Department of Chiropractic Medicine, Faculty of Medicine, Balgrist University Hospital, University of Zurich, Zurich, Switzerland. Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. Clinical Trial Unit, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland. Department of Hematology and Central Hematology Laboratory, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. Department for BioMedical Research, University of Bern, Bern, Switzerland. Department of Biomedicine, University Hospital Basel, Basel, Switzerland. Interregional Blood Transfusion SRC, Bern, Switzerland. University of Lausanne, Lausanne, Switzerland. Institute for Infectious Diseases, University of Bern, Bern, Switzerland. Faculty of Biology and Medicine, Lausanne University Hospital, Lausanne, Switzerland. Center for Thrombosis and Hemostasis, University Medical Center Mainz, Mainz, Germany. Haemostasis Research Unit, University College London, London, UK.

Scientific reports. 2020;10(1):14219
PICO Summary

Population

Non-anaemic blood donors with iron deficiency (n= 405).

Intervention

Single intravenous dose of 800 mg iron-carboxymaltose (n= 203).

Comparison

Placebo (n= 202).

Outcome

At 6 to 8 weeks after intervention, self-rated mean fatigue showed no group difference. Pre-specified subgroup analyses of gender, ferritin < 25 µg/L and fatigue ≥ 4 points, as well as exploratory analyses of lower ferritin cut-offs did not reveal any between-group differences. No group differences were observed for different measures of general well-being and other clinical and safety outcomes. Intravenous iron supplementation compared with placebo resulted in increase of ferritin and hemoglobin levels in repeat blood donors with low iron stores, yet had no effect on fatigue and general well-being.
Abstract
We investigated whether intravenous iron supplementation improves fatigue and general health in non-anemic repeat adult blood donors with iron deficiency (ferritin ≤ 50 µg/L). Of 1,487 potentially eligible participants, 203 were randomly assigned to a single intravenous dose of 800 mg iron-carboxymaltose and 202 to placebo; 393 participants completed the trial. At 6 to 8 weeks after intervention, self-rated mean fatigue scores (numeric rating scale from 1-10, primary outcome) were 3.9 ± 1.8 in the iron supplementation group and 4.0 ± 2.2 in the placebo group, showing no group difference (p = 0.819). Pre-specified subgroup analyses of gender, ferritin < 25 µg/L and fatigue ≥ 4 points, as well as exploratory analyses of lower ferritin cut-offs did not reveal any between-group differences. In terms of secondary outcomes, the mean differences were 114.2 µg/L for ferritin (95% CI 103.1-125.3) and 5.7 g/L for hemoglobin (95% CI 4.3-7.2) with significantly higher values in the iron supplementation group. No group differences were observed for different measures of general well-being and other clinical and safety outcomes. Intravenous iron supplementation compared with placebo resulted in increase of ferritin and hemoglobin levels in repeat blood donors with low iron stores, yet had no effect on fatigue and general well-being.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine