A randomized, blinded, placebo‐controlled trial of education and iron supplementation for mitigation of iron deficiency in regular blood donors

Abstract

BACKGROUND The historical approach of offering dietary advice to donors with low hemoglobin (Hb) is ineffective for preventing iron deficiency in frequent donors. Alternative approaches to maintaining donor iron status were explored. STUDY DESIGN AND METHODS Frequent blood donors were randomly assigned into five arms for 2 years of follow-up. Three double-blinded arms provided 60 once-daily pills after each donation (38, 19, or 0 mg of iron). Two single-blinded arms provided iron status (ferritin) or no information letters after each donation. Ferritin, soluble transferrin receptor, and complete blood count were measured at each donation. RESULTS There were 692 subjects enrolled and 393 completed the study. Subjects in pill groups deenrolled more than those in letter groups (39% vs. 7%). Adverse events occurred equally in subjects receiving iron or placebo pills. Of those completing the study, the prevalence of ferritin of less than 12 or less than 26 ng/mL declined by more than 50% and was statistically indistinguishable in the three intervention groups (19 or 38 mg of iron; iron status letter). Longitudinal analyses of all subjects showed improved iron status in iron pill groups and worsening iron status in control groups (placebo; no information letter). The iron pill groups experienced a net increase of approximately 0.6 g/dL Hb compared to control groups. The iron status letter group had little change in Hb. CONCLUSION Providing 19 or 38 mg of daily iron or iron status information were effective and mostly equivalent interventions for mitigating iron deficiency in regular donors when compared at the end of the 2-year longitudinal phase of the study. Donors without intervention had worsened iron deficiency with continued donation.

Effect of iron supplementation on iron stores and total body iron after whole blood donation

“…However, the very brisk iron response shown in our study in the first 4 weeks indicates that 8 weeks would likely be an adequate recommended supplementation period, even for the reduced dose of 19 mg per day or a somewhat reduced compliance. Findings from STRIDE 16 reinforce the likelihood that an 8 week supplementation period using 19 mg would probably be effective since no difference was noted in response of donor iron and hemoglobin parameters between doses of 19 mg and 38 mg per day, when given to frequent whole blood donors for 8 weeks after a whole blood donation. Finally, we only evaluated responses to iron supplementation after a whole blood donation and did not address iron management following double red cell donation or following multiple plateletpheresis donations.…”

Potential impact on blood availability and donor iron status of changes to donor hemoglobin cutoff and interdonation intervals

“…In contrast, donors assigned iron pills (38 mg) had uniformly accelerated recovery of both Hb and iron levels, with modest variability across donors. Similarly, the STRIDE study, another recently completed RCT, demonstrated that low‐dose iron (19 mg) equivalent to over‐the‐counter formulations available in the United States strongly improved donor Hb and iron levels and sharply reduced their Hb deferrals compared to controls . Importantly, it suggested that merely providing donors information about their iron status after a donation might be sufficient to stimulate donor initiation of iron supplementation.…”

Association of blood donation with iron deficiency among adolescent and adult females in the United States: a nationally representative study

“…Actionable interventions beyond education must also be considered to protect blood donors from iron deficiency . Possibilities include extending the interdonation interval, performing ferritin testing prior to donation, and providing iron supplementation . The efficacy of these interventions is well established, and there is growing evidence to support the feasibility of implementing these interventions.…”