High-dose intravenous versus oral iron in blood donors with iron deficiency: The IronWoMan randomized, controlled clinical trial

Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, Graz, Austria. Department for Anesthesiology and Intensive Care, Medical University of Graz, Graz, Austria. Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz, Austria. University Hospital Graz, Clinical Institute of Medical and Chemical Laboratory Diagnostics, Graz, Austria. Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria. Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria; Thyroid Endocrinology Osteoporosis Institute Dobnig Graz, Jakob-Redtenbachergasse 10, 8010, Graz, Austria. Electronic address: karin.amrein@medunigraz.at.

Clinical nutrition (Edinburgh, Scotland). 2019
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PICO Summary

Population

Blood donors with iron deficiency, enrolled in the IronWoMan randomised controlled trial (n= 176).

Intervention

Single dose of intravenous ferric carboxymaltose (n= 86).

Comparison

Oral iron ferrous fumarate (n= 90).

Outcome

At follow-up, median (IQR) transferrin saturation and ferritin were significantly higher in the intravenous group, 27 (23-35) % vs. 21.0 (16-32) %; and 105 (75-145) ng/mL vs. 25 (17-34) ng/mL, respectively; while median (IQR) haemoglobin levels were comparable for intravenous, 13.6 (13.0-14.4) g/dL vs. oral, 13.6 (13.0-14.2) g/dL. The frequency of adverse effects was comparable (38% in both groups) and no serious adverse events occurred.
Abstract
INTRODUCTION Frequent blood donation often leads to iron deficiency and even anemia but appropriate strategies for detection and prevention are currently not mandatory. At the Medical University of Graz, we conducted a single-center prospective clinical trial to compare oral and IV iron supplementation in iron deficient blood donors including Austrian regular whole blood and platelet apheresis donors. We aimed to determine the difference of transferrin saturation between the treatment groups 8-12 weeks iron administration besides other parameters of iron status and blood count. METHODS 176 healthy male and female blood donors with iron deficiency (ferritin ≤30 ng/mL) were randomized to either a single dose of IV ferric carboxymaltose (1000 mg, n = 86) or oral iron (II)fumarate (100 tablets of 100 mg [10 per week], n = 90). RESULTS Between 2014 and 2016, 172 donors (137 women) completed the study; 4 in the oral group were lost to follow-up. At follow-up, median (IQR) transferrin saturation and ferritin were significantly higher in the intravenous group (27 [23-35]%, vs 21.0 [16-32]%; p < 0.001 and 105 [75-145] ng/mL vs 25 [17-34] ng/mL; p < 0.001, respectively) while median (IQR) hemoglobin levels were comparable (IV, 13.6 [13.0-14.4] g/dL vs oral, 13.6 [13.0-14.2] g/dL). The frequency of adverse effects was comparable (38% in both groups) and no serious adverse events occurred. CONCLUSIONS A single dose of 1000 mg of intravenous iron is highly effective to counteract iatrogenic iron deficiency in blood donors. Oral iron appears to be an acceptable alternative. The assessment of body iron stores should play a key role in maintaining blood donors' health. This trial was registered at www.clinicaltrials.gov as NCT01787526 on February 8, 2013 and at www.clinicaltrialsregister.eu (EudraCT identifier: 2013-000327-14) on September 24, 2013.
Study details
Language : eng
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