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Iron Replacement in Blood Donors

18 Years
Not Enrolling
Iron Deficiency

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Trial Information

Iron Replacement in Blood Donors

Iron is an essential element that is lost with each blood donation. In order for a donor to
compensate for the iron lost in donating blood, iron is mobilized from the body's iron
stores and absorption of iron from the diet is increased. However, this balance is often
difficult to maintain in premenopausal women and regular blood donors since there is ongoing
blood loss. Deficiency in iron results in reduced hemoglobin values, iron stores, and
eventually iron deficiency anemia if not treated. Iron deficiency presents a problem in
blood centers since the minimum allowable hemoglobin for blood donation is 12.5 g per dL.

In the Department of Transfusion Medicine at the NIH, 14.6% of donors presenting for whole
blood donation and 7.7% of donors presenting for apheresis platelet donation are deferred on
at least one occasion per year due to low hemoglobin values. Overall, 7.9% of visits for
whole blood donation and 2.1% of visits for apheresis platelet donation result in donor
deferral due to low hemoglobin. Although the challenge of iron depletion in the blood donor
population has been known for decades, little has been undertaken to resolve this issue.
Several authors have reported data from successful short term projects demonstrating the
safety and efficacy of iron replacement in donors, but larger long term studies have not
been reported.

The objectives of this protocol are to: (1) quantitate the prevalence of iron deficiency in
first-time presumably healthy individuals who present for blood donation; (2) study the
effects of long-term blood donation on donors' hemoglobin levels and iron stores; (3)
evaluate the safety, practicality, and efficacy of distributing oral replacement iron to
blood donors; (4) determine the effect of oral iron replacement therapy on the donor pool
by monitoring deferral rates for low hemoglobin before and after the initiation of an iron
replacement program. The goal of these objectives is to treat and prevent iron deficiency
in prospective and regular blood donors, thereby expanding the eligible donor pool and
leading to increased donor satisfaction and retention by decreasing deferral rates due to
low hemoglobin.

Inclusion Criteria


- Subjects must meet all allogeneic donor eligibility criteria established by the NIH
Department of Transfusion Medicine, American Association of Blood Banks, and the Food
and Drug Administration

- Subjects must meet all research donor eligibility established by the NIH Department
of Transfusion Medicine, per protocol 99-CC-0168

- Subjects must be 18 years of age or older

- Subjects must be willing to sign consent and participate in the protocol


- Ineligible for volunteer or research blood donation, per DTM, AABB, or FDA criteria

- Subjects who refuse to sign the protocol consent document

- Subjects diagnosed with hereditary hemochromatosis

Type of Study:


Study Design:

Time Perspective: Prospective

Principal Investigator

Stephen J O'Brien, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

May 2006

Completion Date:

March 2012

Related Keywords:

  • Iron Deficiency
  • Hemoglobin
  • Iron Supplementation
  • Donor Retention
  • Iron Stores
  • Ferritin
  • Transferrin Saturation
  • Healthy Volunteer
  • HV
  • Blood Donors
  • Anemia, Iron-Deficiency



National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892