Iron DeficiencyNCT00327067
Iron Replacement in Blood Donors
An observational study of Iron Deficiency, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency
- How many people
- 1,820 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2006to 1 Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Iron Deficiency
- Keywords
- Hemoglobin, Iron Supplementation, Donor Retention, Iron Stores, Ferritin, Transferrin Saturation, Healthy Volunteer, HV, Blood Donors
- Medical subject headings
- Iron Deficiencies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study start12 May 2006
- Study completion1 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,820 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Investigators
- Stephen J O'Brien, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327067
- Sponsor's protocol ID
- 060166
- Other IDs
- 06-CC-0166
- Status last verified
- 1 Mar 2012
- First submitted
- 17 May 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Davey RJ. Recruiting blood donors: challenges and opportunities. Transfusion. 2004 Apr;44(4):597-600. doi: 10.1111/j.0041-1132.2004.04402.x. No abstract available.
PubMed 15043578Gordeuk 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. doi: 10.1046/j.1537-2995.1987.27187121482.x.
PubMed 3810831Radtke 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. doi: 10.1111/j.1537-2995.2004.04074.x.
PubMed 15383014
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Replacement in Blood Donors
- ClinicalTrials.gov ID
- NCT00327067
- Acronym / sponsor ID
- 060166
- Conditions
- Iron Deficiency
- Keywords
- Hemoglobin, Iron Supplementation, Donor Retention, Iron Stores, Ferritin, Transferrin Saturation, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,820 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 12 May 2006
- Study completion
- 1 Mar 2012
- First posted
- 18 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 15043578Davey RJ. Recruiting blood donors: challenges and opportunities. Transfusion. 2004 Apr;44(4):597-600. doi: 10.1111/j.0041-1132.2004.04402.x. No abstract available.
- Background: PubMed 3810831Gordeuk 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. doi: 10.1046/j.1537-2995.1987.27187121482.x.
- Background: PubMed 15383014Radtke 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. doi: 10.1111/j.1537-2995.2004.04074.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen J O'Brien, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00327067, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.