Abstract
BackgroundAbout 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.Methods/designIn 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.DiscussionIron 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.Trial registrationEudraCT: 2013-000327-14, Clinical Trials Identifier: NCT01787526. Registered on 6 February 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1648-y) contains supplementary material, which is available to authorized users.
Highlights
About 2–3 % of the population participates in blood donation programmes
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 improve blood donor wellbeing
Our hypothesis is that 1 g of intravenously infused ferric carboxymaltose will improve the iron status of blood donors with iron deficiency more efficiently compared to a comparable dose of oral iron supplements (10 g assuming a 10 % resorption rate, given over 8–12 weeks)
Summary
Iron deficiency anaemia occurs when iron stores have been consumed [1]. Before establishment of anaemia, iron deficiency may have other, more subtle and unspecific adverse effects on an individual such as decreased physical and cognitive performance [41, 42]. If our study can establish that intravenous iron is feasible in blood donors and the substantial impediments like costs and logistics can be overcome, high-dose intravenously infused iron given immediately after whole blood or apheresis donation through the present venous access could be a very efficient way for correction and/or prevention of iatrogenic iron deficiency. Such an approach could protect blood donors from symptoms related to iron deficiency and help to maintain an iron-replete blood donor pool.
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