Impact of iron supplementation among anemic voluntary first-time blood donors: Results from the BLOODSAFE pilot trial in Ghana

Introduction: 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. Materials and Methods: 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. Results: 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. Conclusion: 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.