title: High-dose intravenously administered iron versus orally administered iron in blood donors with iron deficiency: study protocol for a randomised, controlled trial.
abstract: About 2-3 % of the population participates in blood donation programmes. Each whole blood donation or ten apheresis donations cause a loss of 200-250 mg of iron. As a result, one of the most common risks of regular blood donors is iron deficiency. Although this has been known for decades, in most countries, iron status is currently not assessed or treated in this population. Premenopausal women are particularly affected, as they have lower iron reserves and higher daily requirements. Besides anaemia, iron deficiency may lead to fatigue and impaired cognitive and physical performance. Current iron preparations for intravenous administration are well tolerated and allow for application of large doses up to 1 g in one visit. Our hypothesis is that in blood donors with iron deficiency, intravenously administered iron is more efficient and as safe as oral iron supplementation. Since anaemia is one of the most frequent reasons for permanent or intermittent donor deferral, maintaining an iron-replete donor pool may help to prevent shortages in blood supply and to avoid iron deficiency-related comorbidities.
  
  
  
  In this randomised clinical trial we include male and female blood donors aged ≥18 and ≤65 years with a ferritin value of ≤30 ng/ml. Stratified by gender, participants are randomized with a web-based randomisation tool in a 1:1 ratio to either 1 g of intravenously administered ferric carboxymaltose or 10 g of iron fumarate supplements at one to two daily doses of 100 mg each. Eight to 12 weeks after the first visit, iron status, blood count and symptoms are assessed in both groups. The primary endpoint is the difference in transferrin saturation (%) following the intervention between both groups. Secondary endpoints include other parameters of iron metabolism and red blood cell count, the number of patients with drug-related adverse events, and subjective symptoms including those of the restless legs syndrome, quality of life, and fatigue.
  
  
  
  Iron supplementation administered intravenously in non-anaemic but iron-deficient blood donors could represent an effective strategy to protect blood donors from comorbidities related with iron deficiency and therefore improve blood donor wellbeing. Furthermore, iron supplementation will help to maintain an iron-replete blood donor pool.
  
  
  
  EudraCT: 2013-000327-14, Clinical Trials Identifier: NCT01787526 . Registered on 6 February 2013.
authors: Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, Graz, Austria.
authors: Susanne
authors: S
authors: Macher
authors: Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, Graz, Austria.
authors: Camilla
authors: C
authors: Drexler
authors: Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, Graz, Austria.|Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.
authors: Ines
authors: I
authors: Lindenau
authors: Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, Graz, Austria.
authors: Nazanin
authors: N
authors: Sareban
authors: Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, Graz, Austria.
authors: Peter
authors: P
authors: Schlenke
authors: Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria. karin.amrein@medunigraz.at.
authors: Karin
authors: K
authors: Amrein
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D015415:Biomarkers; D001782:Blood Donors / Q000600:supply & distribution*; D002985:Clinical Protocols; D003677:Deficiency Diseases / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D004906:Erythrocyte Count; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D005296:Ferrous Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D007501:Iron / Q000097:blood; D000090463:Iron Deficiencies; D008297:Male; D008320:Maltose / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D008875:Middle Aged; D011446:Prospective Studies; D012107:Research Design; D013997:Time Factors; D014168:Transferrin / Q000378:metabolism; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D015415:Biomarkers; D005290:Ferric Compounds; D005296:Ferrous Compounds; D006397:Hematinics; D014168:Transferrin; C522335:ferric carboxymaltose; D008320:Maltose; D007501:Iron; C031621:ferrous fumarate
keywords: Blood donation; Donor safety; Intravenous iron; Iron carboxymaltose; Iron deficiency; Randomised controlled trial