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

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 8e12 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 ¼ 86) or oral iron (II)fumarate (100 tablets of 100 mg [10 per week], n ¼ 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 [23e35]%, vs 21.0 [16e32]%; p < 0.001 and 105 [75e145] ng/mL vs 25 [17 e34] ng/mL; p < 0.001, respectively) while median (IQR) hemoglobin levels were comparable (IV, 13.6 [13.0e14.4] g/dL vs oral, 13.6 [13.0e14.2] 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.

The Effect of Parenteral or Oral Iron Supplementation on Fatigue, Sleep, Quality of Life and Restless Legs Syndrome in Iron Deficient Blood Donors: A Secondary Analysis of the Ironwoman Rct

“…All the biochemical data have been published previously 32 . In brief, the primary endpoint, transferrin saturation, was significantly higher after IV iron (27 [23][24][25][26][27][28][29][30][31][32][33][34][35] Four patients (all in the oral iron group) were lost to follow-up. Participants recommended both treatments (IV 91% vs. PO 79%) and adherence was excellent in both groups (IV 100%, PO 95% who took >90 capsules).…”

“…Headache, dyspnea and dizziness improved significantly in our study. However, this may also be explained with the high percentage of anemic blood donors after the last blood donation and before iron therapy (73% of women and 82% of men) with a mean Hb of 11.7 g/dl and with the higher mean Hb of 13.6 g/dl after iron supplementation 32 . Interestingly, there was no difference between IV and oral iron therapy and the attained ferritin concentration at visit 1, although our study was certainly underpowered for such analyses.…”

“…In the IronWoMan trial, we randomized iron deficient blood donors to a single high dose of intravenous ferric carboxymaltose or to oral iron for 10 weeks 32 . In this pre-planned secondary analysis, we aimed to assess the prevalence and severity of different clinical symptoms related to iron deficiency before and after iron therapy with intravenous or oral iron.…”

“…%, vs. 21[16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32]% compared to PO; p<0.001), as was the ferritin level (IV 105 [75-145] vs. PO 25 [17-34] ng/mL; p<0.001). Anemia was present in 75% of all donors at V0.…”

The Effect of Parenteral or Oral Iron Supplementation on Fatigue, Sleep, Quality of Life and Restless Legs Syndrome in Iron-Deficient Blood Donors: A Secondary Analysis of the IronWoMan RCT

“…In the IronWoMan trial, we randomized 176 iron-deficient blood donors (138 women, 38 men) to a single high dose of intravenous ferric carboxymaltose (1000 mg) or to oral iron (II)fumarate (100 capsules, 100 mg each) for 10 weeks. The primary endpoint was the difference in transferrin saturation between the two groups after 8–12 weeks [ 32 ]. Both median transferrin saturation and ferritin levels were significantly higher in the intravenous group (27% vs. 21%; p < 0.001 and 105 vs. 25 ng/mL; p < 0.001, respectively) while median hemoglobin levels were comparable (IV, 13.6g/dL vs. oral, 13.6 g/dL).…”