CARBONYL IRON SUPPLEMENTATION FOR BLOOD DONORS

The proposed demonstration and education research project is designed to show that carbonyl iron supplementation is an effective means of increasing blood donations from women of childbearing age. Carbonyl iron has a bioavailability similar to that of ferrous sulfate but is a safe, non-toxic form of elemental iron that virtually eliminates the risk of iron poisoning in children. Iron deficiency is the most common medical cause of deferral from donation. Deferral from donation has important social and psychological consequences for donors and is a major factor affecting the commitment of women to blood donation. The proposed research project will examine the physiological, economic and social-psychological consequences of giving carbonyl iron once daily for 56 days after each blood donation to women who are "VIP donors" (women already committed to donating at least units of blood each year) using a prospective, controlled, randomized experimental design. The primary hypothesis of the demonstration project is that short-term, low dose carbonyl iron supplementation after each blood donation is an effective means of increasing blood donations from women of childbearing age. Subsidiary hypotheses are that carbonyl iron supplementation for female donors is (i) cost-effective and will have (ii) physiological consequences that decrease the prevalence of iron deficiency and low hemoglobin concentration and (iii) social and psychological effects that enhance the commitment of women as donors. The proposed demonstration project will examine the effectiveness of short-term, low dose carbonyl iron supplements after blood donation udder conditions virtually identical to actual blood center practice. The study population will consist of about 4000 menstruating women, 18 to 40 years of age, who participate in the VIP program of the American Red Cross Northern Ohio Blood Services in 4 districts that use only bloodmobiles as donation sites. Each Study District will be randomly assigned to interventions for menstruating female VIP donors consisting of (i) current practice by blood centers (i.e. no iron supplement offered, unscheduled donation visits), (ii) scheduled donation appointments (with no iron supplement offered), (iii) offering iron supplements with scheduled donation appointments, and (iv) offering iron supplements with unscheduled donation visits. The primary study comparison will be between donors treated with carbonyl iron with unscheduled visits and those managed by current practice with respect to the number of units donated over 36 months. Subsidiary comparisons of all groups will be made to examine the effects of iron supplements, scheduling, or both on the amount of blood donated, cost-effectiveness, and physiological, social and psychological effects. The results of this research could provide the scientific, economic and practical basis for the adoption of short-term carbonyl iron supplementation for female donors as a standard procedure for blood centers and lead to an increase in the national blood supply.