Caring for Those Who Share: Mitigating Iron Deficiency in Regular Blood Donors

描述(申请人提供)：定期献血引起的缺铁是血液中心面临的问题。每一次献血都会从献血者体内去除200到250毫克的铁。因此，许多捐赠者因反复捐献而变得缺铁。这对血液中心提出了一个挑战，近年来这种挑战变得更加尖锐，因为人们意识到，即使在没有贫血的情况下，缺铁也与包括疲劳和运动耐力下降在内的不良反应以及认知功能下降、异食癖和不宁腿综合征等神经症状有关。REDS-II(NHLBI逆转录病毒流行病学捐赠者研究-II)是一个由分布在美国各地的6个血液中心组成的联盟。REDS-II研究人员进行了一项纵向研究，在两年的时间里调查了献血者的铁状况，称为REDS-II捐献者铁状况评估(RISE)。对定期捐赠者(每年2次捐献(女性)或每年3次捐献(男性))的基线分析结果显示，三分之二以上的女性捐赠者和一半以上的男性捐赠者患有缺铁。为了保障献血者的健康和防止承诺献血者的流失，血液中心已经到了解决献血者缺铁问题的时候了。在这里，我们建议利用一个由三个REDS-II血液中心组成的联合体来评估预防/缓解献血者铁缺乏的潜在干预措施。拟议研究的受试者将从RISE捐赠者中招募。这些捐赠者的铁状况在两年内得到了很好的研究，这将使我们能够评估两项研究之间总共四年时间内实验室数据、捐献经验和捐赠者症状的变化。在具体目标1中，我们将确定向捐赠者提供有关其铁状况的准确信息和适当的行动方案，如延长捐献间隔或服用铁补充剂，是否会影响他们采取独立步骤改善其铁状况。在具体目标2中，我们将为献血者提供60天的多种维生素供应，这些维生素由38毫克、19毫克或0毫克的元素铁组成，可在每次献血后服用。这两个特定目标的主要结果是通过测量血浆铁蛋白、血浆可溶性转铁蛋白受体和网织红细胞血红蛋白含量来确定干预措施如何改变供体铁状况。次要结果是确定干预措施如何改变成功采集一单位血液的献血者就诊比例，以及它们如何改变导致红细胞压积降低的献血者就诊比例。第三种结果是确定干预措施如何改变供者疲劳、异食癖和不宁腿综合症的患病率，这是在研究开始和结束时进行的一项调查所评估的。拟议研究的结果将提供有关献血者铁替代的各种方法的有效性的重要信息，并为社区血液中心易于实施的有效计划奠定基础。 公共卫生相关性：全血捐献会去除献血者体内的铁，并可能在反复献血后导致铁缺乏。这项拟议研究的主要目标是开发预防/缓解定期献血者铁缺乏的计划。这将有助于改善公共健康，防止献血者铁缺乏的不良后果，如疲劳和运动耐力下降，以及神经症状，如认知功能下降，异食癖和不宁腿综合症。

DESCRIPTION (provided by applicant): Iron deficiency caused by regular blood donation is a problem facing blood centers. Each blood donation removes 200 to 250 mg of iron from the donor. Consequently, many donors become iron deficient with repeated donation. This presents a challenge to blood centers that has become more acute in recent years with the realization that iron deficiency even in the absence of anemia is associated with adverse effects including fatigue and decreased exercise tolerance, as well as neurological symptoms such as decreased cognitive function, pica and restless leg syndrome. REDS-II (NHLBI Retrovirus Epidemiology Donor Study-II) is a consortium of 6 blood centers located across the United States. REDS-II investigators performed a longitudinal study investigating the iron status of blood donors over a two year period called the REDS-II Donor Iron Status Evaluation (RISE). Results from the baseline analysis of regular donors (e 2 donations per year (females) or e 3 donations per year (males) revealed that over two-thirds of female donors and over one-half of male donors have iron deficiency. To both safeguard donor health and prevent the loss of committed blood donors, the time has come for blood centers to address this problem of donor iron deficiency. Here we propose to utilize a consortium of three of the REDS-II blood centers to assess potential interventions that will prevent/mitigate iron deficiency in blood donors. Subjects for the proposed studies will be recruited from RISE donors. The availability of these donors whose iron status is well studied for two years in RISE will allow us to assess changes in laboratory data, donation experience and donor symptoms over a combined 4-year period between the two studies. In Specific Aim 1 we will determine if providing donors with accurate information about their iron status and appropriate courses of action, such as prolonging donation intervals or taking iron supplements, will influence them to take independent steps to improve their iron status. In Specific Aim 2 we will provide donors with a 60-day supply of multiple vitamins formulated with 38, 19 or 0 mg of elemental iron to take following each blood donation. The primary outcome for both Specific Aims is to determine how the interventions change donor iron status as assessed by measurement of plasma ferritin, plasma soluble transferrin receptor and reticulocyte hemoglobin content. Secondary outcomes are to determine how the interventions change the proportion of donor visits resulting in successful collection of a unit of blood and how they change the proportion of donor visits resulting in low hematocrit deferral. Tertiary outcomes are to determine how the interventions change the prevalence of donor fatigue, pica and restless leg syndrome as assessed by a survey administered at the beginning and end of the study. Findings from the proposed studies will provide important information on the efficacy of various approaches for iron replacement in blood donors and lay the groundwork for effective programs that can be readily implemented by community blood centers. PUBLIC HEALTH RELEVANCE: Whole blood donation removes iron from the donor and can result in iron deficiency following repeated donation. The primary objective of the proposed studies is to develop programs that will prevent/mitigate iron deficiency in regular blood donors. This will contribute to improved public health by preventing the adverse consequences of iron deficiency in blood donors such as fatigue and decreased exercise tolerance, as well as neurological symptoms such as decreased cognitive function, pica and restless leg syndrome.