Strategies to Reduce Iron Deficiency
| Status: | Completed |
|---|---|
| Conditions: | Iron Deficiency Anemia, Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2011 |
| End Date: | June 2014 |
Caring for Those Who Share: Mitigating Iron Deficiency In Regular Blood Donors
The prevalence of iron deficiency in blood donors has been demonstrated to be a direct
consequence of repeat blood donations. Given the adverse effects of iron deficiency, it is
priority to implement programs to remediate iron deficiency issues associated with blood
donations. To explore this issue, the study's aims to:
1. Determine whether regular blood donors provided with accurate information about their
iron status and written recommended courses of action will take steps to
prevent/mitigate iron deficiency on their own without being given iron supplements by
the blood center; and
2. Determine if two different amounts of iron provided by the blood center will
prevent/mitigate iron deficiency in regular blood donors.
To conduct this randomized, placebo controlled study, participant donors will be assigned to
one of two arms and followed for a 24 month period. Each subject will provide additional
blood samples of 7 ml and 4.5 ml at each study visit for the purpose of tracking hemoglobin
(Hgb), ferritin, soluble transferrin receptor (sTfR), and hematology laboratory results.
Under the two study arms, subjects are to be randomized into one of the following five
blinded categories:
- Receive a thank you letter after each blood donation.
- Receive a letter informing them of their ferritin result at each visit, along with
recommendations for blood donation.
- Receive pills to take daily that contain no iron (a placebo or inert pill).
- Receive pills to take daily that contain 19 mg of iron (the typical amount in a
multivitamin with iron).
- Receive pills to take daily that contain 38 mg iron (the typical amount in an
over-the-counter iron supplement).
consequence of repeat blood donations. Given the adverse effects of iron deficiency, it is
priority to implement programs to remediate iron deficiency issues associated with blood
donations. To explore this issue, the study's aims to:
1. Determine whether regular blood donors provided with accurate information about their
iron status and written recommended courses of action will take steps to
prevent/mitigate iron deficiency on their own without being given iron supplements by
the blood center; and
2. Determine if two different amounts of iron provided by the blood center will
prevent/mitigate iron deficiency in regular blood donors.
To conduct this randomized, placebo controlled study, participant donors will be assigned to
one of two arms and followed for a 24 month period. Each subject will provide additional
blood samples of 7 ml and 4.5 ml at each study visit for the purpose of tracking hemoglobin
(Hgb), ferritin, soluble transferrin receptor (sTfR), and hematology laboratory results.
Under the two study arms, subjects are to be randomized into one of the following five
blinded categories:
- Receive a thank you letter after each blood donation.
- Receive a letter informing them of their ferritin result at each visit, along with
recommendations for blood donation.
- Receive pills to take daily that contain no iron (a placebo or inert pill).
- Receive pills to take daily that contain 19 mg of iron (the typical amount in a
multivitamin with iron).
- Receive pills to take daily that contain 38 mg iron (the typical amount in an
over-the-counter iron supplement).
Inclusion Criteria
- Donors who have donated whole blood or double red cells ≥ 2 times in the last 12 months
if female, or, ≥ 3 times in the last 12 months if male.
- Commitment to meet the donation frequency requirement for the study for two more years,
give a blood sample at each visit, and complete baseline and follow-up surveys.
Exclusion Criteria
- Subjects < 18 years of age.
- Subjects taking iron supplements (including multivitamins with iron) up to one month
prior to enrollment.
- Females who are pregnant or plan to become pregnant in the following 2 years.
- Subjects unwilling to meet the requirements of the study.
- Donors who have donated whole blood or double red cells ≥ 2 times in the last 12 months
if female, or, ≥ 3 times in the last 12 months if male.
- Commitment to meet the donation frequency requirement for the study for two more years,
give a blood sample at each visit, and complete baseline and follow-up surveys.
Exclusion Criteria
- Subjects < 18 years of age.
- Subjects taking iron supplements (including multivitamins with iron) up to one month
prior to enrollment.
- Females who are pregnant or plan to become pregnant in the following 2 years.
- Subjects unwilling to meet the requirements of the study.
Inclusion Criteria:
- Repeat donors who have previously participated in RISE study and have continued to
donate at a required frequency (donated whole blood or double red cells ≥ 2 times in
the last 12 months if female, or, ≥ 3 times in the last 12 months if male)
- Non-RISE donors who have donated whole blood or double red cells ≥ 2 times in the
last 12 months if female, or, ≥ 3 times in the last 12 months if male
- commitment to meet the donation frequency requirement for this study for two more
years, give a blood sample at each visit, and complete baseline and follow-up surveys
Exclusion Criteria:
- subjects < 18 years of age
- subjects taking iron supplements (including multivitamins with iron) up to one month
prior to enrollment
- females who are pregnant or plan to become pregnant in the following 2 years
- subjects unwilling to meet the requirements of the study
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