Dei-Adomakoh Yvonne, Olayemi Edeghonghon, Telke Susan, Asamoah-Akuoko Lucy, Appiah Bernard, Segbefia Catherine, Ward Caitlin, Tancred Tara, Yawson Alfred Edwin, Adu-Afarwuah Seth, Akwasi-Kuma Amma Benneh, Ofori-Acquah Solomon Fiifi, Adongo Philip Baba, Acquah Michael Ebo, Ametorwo Reena, Bates Imelda, Agyei Francis, Delaney Meghan, Reilly Cavan
Department of Haematology, University of Ghana Medical School, Accra, Ghana.
Coordinating Centers for Biometric Research, Division of Biostatistics, University of Minnesota Research, City-Twin cities, minnesota, USA.
Transfusion. 2025 Jan;65(1):131-139. doi: 10.1111/trf.18082. Epub 2024 Nov 30.
In sub-Saharan Africa (SSA), an adequate supply of safe blood for transfusion is a major developmental challenge. In Ghana, deferral from blood donation for anemia accounts for nearly half of the ineligible blood donors. We conducted a longitudinal two-arm parallel-group non-inferiority trial to test if iron supplementation among blood donors with iron deficiency (ID) or anemia could increase their hemoglobin levels to near those without ID or anemia.
A structured questionnaire was used to collect participants' sociodemographic and medical information after written informed consent was obtained. Blood samples were analyzed for full blood count (FBC), serum ferritin, malaria rapid test, and a peripheral blood smear. The primary outcome was hemoglobin level after 4 months comparing anemic donors who received iron supplementation to the standard of care participants, nonanemic donors who did not receive iron supplementation. All donors received nutritional counseling.
Adherence to low-dose iron supplementation three times a week was poor. Hemoglobin levels in the iron supplementation arm were not close enough to those in the control group after 4 months of iron supplementation to declare non-inferiority. However, non-inferiority was met when the 4 month hemoglobin comparison was restricted to female donors.
After 4 months of iron supplementation, hemoglobin levels in the iron supplementation group did not sufficiently match those in the control group to declare non-inferiority. Data from this pilot trial informed and shaped the design of a larger randomized control type 1 pragmatic effectiveness implementation hybrid trial which is currently ongoing.
在撒哈拉以南非洲地区（SSA），确保充足的安全输血用血供应是一项重大的发展挑战。在加纳，因贫血而延期献血的人数几乎占不合格献血者的一半。我们开展了一项纵向双臂平行组非劣效性试验，以检验缺铁（ID）或贫血的献血者补充铁剂后，其血红蛋白水平能否接近无ID或贫血的献血者。
在获得书面知情同意后，使用结构化问卷收集参与者的社会人口统计学和医学信息。对血样进行全血细胞计数（FBC）、血清铁蛋白、疟疾快速检测和外周血涂片分析。主要结局是4个月后的血红蛋白水平，将接受铁剂补充的贫血献血者与接受标准护理的参与者、未接受铁剂补充的非贫血献血者进行比较。所有献血者均接受营养咨询。
每周三次低剂量铁剂补充的依从性较差。补充铁剂4个月后，铁剂补充组的血红蛋白水平与对照组的差距不够小，无法判定为非劣效。然而，当4个月血红蛋白比较仅限于女性献血者时，达到了非劣效性。
补充铁剂4个月后，铁剂补充组的血红蛋白水平与对照组的匹配程度不足以判定为非劣效。这项试点试验的数据为目前正在进行的一项更大规模的随机对照1型实用有效性实施混合试验的设计提供了参考并对其进行了完善。
