Iron Replacement in Blood Donors

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00327067
First received: May 17, 2006
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

Blood donors who have a low fingerstick hemoglobin level are usually deferred from donating. A possible solution to the problem of repeated deferrals might be for Blood Banks to offer donors with low hemoglobin levels oral iron supplements. To determine the feasibility of such a program, this study will:

  • Determine the frequency of iron deficiency in first-time and repeat blood donors
  • Examine the effects of long-term blood donation on donor hemoglobin levels and iron stores
  • Compare body iron stores in donors who have low hemoglobin values with that of donors who have acceptable hemoglobin values at the time of donation
  • Determine what conditions other than iron deficiency lead to low hemoglobin levels in blood donors
  • Determine the safety and effectiveness of giving oral iron tablets to donors with low hemoglobin levels
  • Monitor the effect of oral iron administration on donor satisfaction and donor retention.

First-time and repeat blood donors at the NIH Clinical Center Blood Bank 18 years of age and older may be eligible for this study. Participants include prospective donors who have an acceptable hemoglobin value at the time of donation and those whose hemoglobin level is determined to be too low for donation.

All participants do the following:

  • Answer medical questions about their diet, health, and family history of blood disorders.
  • Have blood samples drawn from their arm for testing blood cell counts, iron stores, and other hemoglobin-related tests as appropriate.

Donors with low hemoglobin also:

  • Take iron supplements (ferrous sulfate) to replenish iron stores. (Donors who have previously had unpleasant side effects from ferrous sulfate are offered ferrous gluconate as an alternative.)
  • Undergo evaluation with medical screening and laboratory tests at the time of future blood donations.

Condition
Iron Deficiency

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Iron Replacement in Blood Donors

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 1820
Study Start Date: May 2006
Estimated Study Completion Date: March 2012
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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

EXCLUSION CRITERIA:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327067

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Stephen J O'Brien, Ph.D. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00327067     History of Changes
Other Study ID Numbers: 060166, 06-CC-0166
Study First Received: May 17, 2006
Last Updated: March 14, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Hemoglobin
Iron Supplementation
Donor Retention
Iron Stores
Ferritin
Transferrin Saturation
Healthy Volunteer
HV
Blood Donors

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014