{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,5]],"date-time":"2026-06-05T02:59:35Z","timestamp":1780628375099,"version":"3.54.1"},"reference-count":21,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2018,2,9]],"date-time":"2018-02-09T00:00:00Z","timestamp":1518134400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Pharmacosmos A\/S"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2018,4]]},"abstract":"<jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>This trial evaluated the efficacy and safety of intravenous (IV) iron isomaltoside (Monofer) in comparison with placebo in first\u2010time female blood donors.<\/jats:p><\/jats:sec><jats:sec><jats:title>STUDY DESIGN AND METHODS<\/jats:title><jats:p>The trial was a prospective, double blind, placebo\u2010controlled, randomized, comparative, single\u2010center trial of 85 first\u2010time female blood donors. The subjects were randomly assigned 1:1 to either 1000 mg IV iron isomaltoside infusion or placebo. The primary endpoint of the trial was change in hemoglobin (Hb) from baseline to right before the third blood donation.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>The increase in Hb was significantly higher for iron isomaltoside compared with placebo right before both the second blood donation (p <jats:italic>=<\/jats:italic> 0.0327) and the third blood donation (primary endpoint, p <jats:italic>&lt;<\/jats:italic> 0.0001). Improvements in other iron\u2010related variables (plasma iron, plasma ferritin, transferrin saturation, and reticulocyte count) in favor of iron isomaltoside were also observed. The trial was not powered on patient\u2010reported outcomes. However, improvements in iron stores and Hb levels after iron isomaltoside administration were supported by the fact that several of the fatigue symptoms scores showed numerical differences in favor of iron isomaltoside. There were no differences in side effects between the groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p>In iron\u2010deficient female blood donors a single IV iron isomaltoside administration resulted in an improvement in Hb concentration and iron stores and demonstrated a favorable safety profile comparable to placebo.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.14521","type":"journal-article","created":{"date-parts":[[2018,2,9]],"date-time":"2018-02-09T11:59:24Z","timestamp":1518177564000},"page":"974-981","source":"Crossref","is-referenced-by-count":19,"title":["Intravenous iron isomaltoside improves hemoglobin concentration and iron stores in female iron\u2010deficient blood donors: a randomized double\u2010blind placebo\u2010controlled clinical trial"],"prefix":"10.1111","volume":"58","author":[{"given":"Mikkel","family":"Gybel\u2010Brask","sequence":"first","affiliation":[{"name":"Section for Transfusion Medicine, Department of Clinical Immunology Rigshospitalet, Copenhagen University Hospital Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jens","family":"Seeberg","sequence":"additional","affiliation":[{"name":"Section for Transfusion Medicine, Department of Clinical Immunology Rigshospitalet, Copenhagen University Hospital Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars L.","family":"Thomsen","sequence":"additional","affiliation":[{"name":"Aalborg University Aalborg Denmark"},{"name":"Pharmacosmos A\/S Holbaek Denmark."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P\u00e4r I.","family":"Johansson","sequence":"additional","affiliation":[{"name":"Section for Transfusion Medicine, Department of Clinical Immunology Rigshospitalet, Copenhagen University Hospital Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,2,9]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12518"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/0925-5710(95)00426-2"},{"key":"e_1_2_8_4_1","unstructured":"Commission Directive 2004\/33\/EC of 22 March 2004 implementing Directive 2002\/98\/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components. 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