Background: About 2ââ?¬â??3 % of the population participates in blood donation programmes. Each whole blood donation\nor ten apheresis donations cause a loss of 200ââ?¬â??250 mg of iron. As a result, one of the most common risks of regular\nblood donors is iron deficiency. Although this has been known for decades, in most countries, iron status is currently not\nassessed or treated in this population. Premenopausal women are particularly affected, as they have lower iron reserves\nand higher daily requirements. Besides anaemia, iron deficiency may lead to fatigue and impaired cognitive and physical\nperformance. Current iron preparations for intravenous administration are well tolerated and allow for application of large\ndoses up to 1 g in one visit. Our hypothesis is that in blood donors with iron deficiency, intravenously administered iron\nis more efficient and as safe as oral iron supplementation. Since anaemia is one of the most frequent reasons for\npermanent or intermittent donor deferral, maintaining an iron-replete donor pool may help to prevent shortages in\nblood supply and to avoid iron deficiency-related comorbidities.\nMethods/design: In this randomised clinical trial we include male and female blood donors aged ââ?°Â¥18 and ââ?°Â¤65 years\nwith a ferritin value of ââ?°Â¤30 ng/ml. Stratified by gender, participants are randomized with a web-based randomisation tool\nin a 1:1 ratio to either 1 g of intravenously administered ferric carboxymaltose or 10 g of iron fumarate supplements at\none to two daily doses of 100 mg each. Eight to 12 weeks after the first visit, iron status, blood count and symptoms are\nassessed in both groups. The primary endpoint is the difference in transferrin saturation (%) following the intervention\nbetween both groups. Secondary endpoints include other parameters of iron metabolism and red blood cell count, the\nnumber of patients with drug-related adverse events, and subjective symptoms including those of the restless legs\nsyndrome, quality of life, and fatigue.\nDiscussion: Iron supplementation administered intravenously in non-anaemic but iron-deficient blood donors\ncould represent an effective strategy to protect blood donors from comorbidities related with iron deficiency\nand therefore improve blood donor wellbeing. Furthermore, iron supplementation will help to maintain an\niron-replete blood donor pool.
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