Supplementary Material for: Pilot Study to Gain First Indications for the Impact of a 3-Month’s Oral Intake of a Sucrosomial Iron Supplement on Hemoglobin in Iron-Deficient Blood Donors

<b><i>Introduction:</i></b> Regular whole blood donors often suffer from iron deficiency (ID) or iron deficiency anemia due to the loss of 200–300 mg of iron with each donation. Hemoglobin (Hb) as donor eligibility criterion reflects iron stores only poorly. ID in blood donors is typically prevented or treated with orally administered ferrous salts, which frequently cause gastrointestinal side effects. A high daily oral iron dose is counterproductive due to hepcidin upregulation. Oral sucrosomial iron (_sucriron) is encapsulated ferric pyrophosphate that may be an option for blood donors due to its supposed high bioavailability and good tolerability. <b><i>Methods:</i></b> This monocentric single-cohort pilot study included fifty whole blood donors (divided into premenopausal women, postmenopausal women, and men) who did not meet Hb donation criteria. Participants aged 18–65 years with ferritin &lt;30 ng/mL and venous Hb &lt;12.5 g/dL in women and Hb &lt;13.5 g/dL in men received oral _sucriron (30 mg iron) for 90–120 days. Primary endpoints were the increase of Hb and ferritin. <b><i>Results:</i></b> Forty-seven participants completed the study. With the limitation that no control group was included, there was a substantial overall median increase of 0.94 g/dL Hb and 4.97 ng/mL ferritin (standardized on 90 days of iron intake). These value improvements were likewise observed in each of the subgroups. _sucriron was very well tolerated, with almost no gastrointestinal side effects identified. <b><i>Conclusion:</i></b> A clear increase of Hb and ferritin was observed after the intake of _sucriron, so it may be a reasonable and useful alternative to traditional oral iron therapy. The ease of administration, pleasant taste, dietary supplement status, and, most importantly, good tolerability highlight the value of _sucriron supplementation.

<b><i>引言：</i></b> 定期全血献血者常因每次献血丢失200~300 mg铁而罹患铁缺乏（iron deficiency, ID）或缺铁性贫血。作为献血合格判定标准的血红蛋白（Hemoglobin, Hb）仅能微弱反映机体铁储备。献血者的铁缺乏通常通过口服亚铁盐进行预防或治疗，但此类药物常引发胃肠道不良反应。每日口服高剂量铁剂会因铁调素（hepcidin）上调而产生反效果。口服蔗糖体铁（oral sucrosomial iron，_sucriron）为包被型焦磷酸铁，因其据称具备高生物利用度与良好耐受性，或可成为献血者的补铁选择。<b><i>方法：</i></b> 本项单中心单队列先导研究纳入50名不符合血红蛋白献血标准的全血献血者，按性别分为绝经前女性、绝经后女性及男性亚组。受试者年龄为18~65岁，铁蛋白（ferritin）＜30 ng/mL，女性静脉血红蛋白＜12.5 g/dL，男性静脉血红蛋白＜13.5 g/dL，给予口服蔗糖体铁（30 mg铁元素），干预时长90~120天。本研究的主要终点为血红蛋白与铁蛋白水平的升高幅度。<b><i>结果：</i></b> 共计47名受试者完成本研究。尽管本研究未设置对照组，存在一定局限性，但整体中位血红蛋白水平升高0.94 g/dL，铁蛋白水平升高4.97 ng/mL（按90天补铁时长进行标准化计算）。各亚组均观察到类似的指标改善。蔗糖体铁耐受性极佳，未发现明显胃肠道不良反应。<b><i>结论：</i></b> 口服蔗糖体铁后，受试者的血红蛋白与铁蛋白水平均出现显著升高，因此其或可成为传统口服铁剂治疗的合理有效替代方案。其给药便捷、口感良好、属于膳食补充剂范畴，而最为关键的优异耐受性，凸显了蔗糖体铁补铁疗法的应用价值。