Protocol Number: 06-CC-0166

Title:

Iron Replacement in Blood Donors

Number:

06-CC-0166

Summary:

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.

Sponsoring Institute:

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility 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-CC0168

- 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

Special Instructions:

Currently Not Provided

Keywords:

Hemoglobin

Iron Supplementation

Donor Retention

Iron Stores

Ferritin

Transferrin Saturation

Recruitment Keyword(s):

Healthy Volunteer

HV

Blood Donors

Condition(s):

Iron Deficiency

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

Warren G. Magnuson Clinical Center

Contact(s):

Julie Hopkins, R.N.
National Institutes of Health
Building 10
Room 1C711
10 Center Drive
Bethesda, Maryland 20892
Phone: (301) 451-8602
Fax: Not Listed
Electronic Address: jahopkins@mail.nih.gov

Citation(s):

Davey RJ. Recruiting blood donors: challenges and opportunities. Transfusion. 2004 Apr;44(4):597-600. No abstract available.

Gordeuk VR, Brittenham GM, Hughes MA, Keating LJ. Carbonyl iron for short-term supplementation in female blood donors. Transfusion. 1987 Jan-Feb;27(1):80-5.

Radtke H, Tegtmeier J, Rocker L, Salama A, Kiesewetter H. Daily doses of 20 mg of elemental iron compensate for iron loss in regular blood donors: a randomized, double-blind, placebo-controlled study. Transfusion. 2004 Oct;44(10):1427-32.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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