Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Macher, S; Drexler, C; Lindenau, I; Sareban, N; Schlenke, P; Amrein, K.
High-dose intravenously administered iron versus orally administered iron in blood donors with iron deficiency: study protocol for a randomised, controlled trial.
Trials. 2016; 17(1):527-527
Doi: 10.1186/s13063-016-1648-y
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- Führende Autor*innen der Med Uni Graz
- Amrein Karin
- Drexler-Helmberg Camilla
- Macher Susanne
- Co-Autor*innen der Med Uni Graz
- Lindenau Ines
- Sareban Nazanin
- Schlenke Peter
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- 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Administration, Oral -
- Adolescent -
- Adult -
- Aged -
- Biomarkers -
- Blood Donors - supply & distribution
- Clinical Protocols -
- Deficiency Diseases - blood
- Deficiency Diseases - diagnosis
- Deficiency Diseases - drug therapy
- Deficiency Diseases - etiology
- Erythrocyte Count -
- Female -
- Ferric Compounds - administration & dosage
- Ferric Compounds - adverse effects
- Ferrous Compounds - administration & dosage
- Ferrous Compounds - adverse effects
- Hematinics - administration & dosage
- Hematinics - adverse effects
- Humans -
- Infusions, Intravenous -
- Iron - blood
- Iron - deficiency
- Male -
- Maltose - administration & dosage
- Maltose - adverse effects
- Maltose - analogs & derivatives
- Middle Aged -
- Prospective Studies -
- Research Design -
- Time Factors -
- Transferrin - metabolism
- Treatment Outcome -
- Young Adult -
- Find related publications in this database (Keywords)
- Blood donation
- Donor safety
- Intravenous iron
- Iron carboxymaltose
- Iron deficiency
- Randomised controlled trial