Iron Deficiency Clinical Trial
Official title:
Iron Replacement in Blood Donors
Verified date | March 1, 2012 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1820 |
Est. completion date | March 1, 2012 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
- 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 |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) |
United States,
Davey RJ. Recruiting blood donors: challenges and opportunities. Transfusion. 2004 Apr;44(4):597-600. — View Citation
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. — View Citation
Radtke H, Tegtmeier J, Röcker 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. — View Citation
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