Iron Replacement in Blood Donors
| Status: | Completed |
|---|---|
| Conditions: | Iron Deficiency Anemia, Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2006 |
| End Date: | March 2012 |
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.
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.
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.
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
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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Click here to add this to my saved trials
