Clinical Trial: Strategies to Reduce Iron Deficiency

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional



Official Title: Caring for Those Who Share: Mitigating Iron Deficiency In Regular Blood Donors

Brief Summary:

The prevalence of iron deficiency in blood donors has been demonstrated to be a direct consequence of repeat blood donations. Given the adverse effects of iron deficiency, it is priority to implement programs to remediate iron deficiency issues associated with blood donations. To explore this issue, the study's aims to:

  1. Determine whether regular blood donors provided with accurate information about their iron status and written recommended courses of action will take steps to prevent/mitigate iron deficiency on their own without being given iron supplements by the blood center; and
  2. Determine if two different amounts of iron provided by the blood center will prevent/mitigate iron deficiency in regular blood donors.

To conduct this randomized, placebo controlled study, participant donors will be assigned to one of two arms and followed for a 24 month period. Each subject will provide additional blood samples of 7 ml and 4.5 ml at each study visit for the purpose of tracking hemoglobin (Hgb), ferritin, soluble transferrin receptor (sTfR), and hematology laboratory results.

Under the two study arms, subjects are to be randomized into one of the following five blinded categories:

  • Receive a thank you letter after each blood donation.
  • Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.
  • Receive pills to take daily that contain no iron (a placebo or inert pill).
  • Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with ir