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| Name | Class |
|---|---|
| Versiti Blood Health | OTHER |
| American National Red Cross | OTHER |
| The Institute for Transfusion Medicine | UNKNOWN |
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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:
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:
Inclusion Criteria
Exclusion Criteria
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letter Group- No information | Placebo Comparator | Receive a thank you letter after each blood donation. |
|
| Letter Group- Information Provided | Experimental | Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation. |
|
| Ferrous gluconate- 0 mg | Placebo Comparator | Receive pills to take daily that contain no iron (a placebo or inert pill). |
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| Ferrous gluconate- 19 mg | Experimental | Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron). |
|
| Ferrous gluconate- 38 mg | Experimental | Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous gluconate- 19 mg | Dietary Supplement | Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin (HgB) | a protein responsible for transporting oxygen in the blood | Change from baseline in HgB over 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Ferritin | a protein that stores iron and releases it when your body needs it | Change from baseline in ferritin over 2 years |
| Soluble transferrin receptor (sTfR) | a protein receptor that is used as a measure of functional iron status and the investigation of iron deficiency anemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Mast, MD, PhD | BloodCenters of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Red Cross, Connecticut Region | Farmington | Connecticut | 06032 | United States | ||
| Westat |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28494509 | Result | Bialkowski W, Kiss JE, Wright DJ, Cable R, Birch R, D'Andrea P, Bryant BJ, Spencer BR, Mast AE. Estimates of total body iron indicate 19 mg and 38 mg oral iron are equivalent for the mitigation of iron deficiency in individuals experiencing repeated phlebotomy. Am J Hematol. 2017 Sep;92(9):851-857. doi: 10.1002/ajh.24784. Epub 2017 Jun 9. | |
| 28164344 |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C011819 | ferrous gluconate |
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| Ferrous gluconate- 38 mg | Dietary Supplement | Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement). |
|
| Letter Group- Information Provided | Other | Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation. |
|
| Letter - No Information Provided | Other | Receive a letter thanking the participant for their participation. |
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| Placebo | Dietary Supplement | Receive pills to take daily that contain 0 mg iron. |
|
| Change from baseline in sTfR over 2 years |
| Laboratory Hematology results | Hemoglobin, Hematocrit, Mean Corpuscular Value (MCV), Mean Corpuscular Hemoglobin (MCH) | Change from baseline in Laboratory hematology results over 2 years. |
| Rockville |
| Maryland |
| 20850 |
| United States |
| The Institute for Transfusion Medicince | Pittsburgh | Pennsylvania | 15220 | United States |
| BloodCenter of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Chansky MC, King MR, Bialkowski W, Bryant BJ, Kiss JE, D'Andrea P, Cable RG, Spencer BR, Mast AE. Qualitative assessment of pica experienced by frequent blood donors. Transfusion. 2017 Apr;57(4):946-951. doi: 10.1111/trf.13981. Epub 2017 Feb 5. |
| 26813849 | Result | Mast AE, Bialkowski W, Bryant BJ, Wright DJ, Birch R, Kiss JE, D'Andrea P, Cable RG, Spencer BR. A randomized, blinded, placebo-controlled trial of education and iron supplementation for mitigation of iron deficiency in regular blood donors. Transfusion. 2016 Jun;56(6 Pt 2):1588-97. doi: 10.1111/trf.13469. Epub 2016 Jan 26. |
| 25469720 | Result | Bialkowski W, Bryant BJ, Schlumpf KS, Wright DJ, Birch R, Kiss JE, D'Andrea P, Cable RG, Spencer BR, Vij V, Mast AE. The strategies to reduce iron deficiency in blood donors randomized trial: design, enrolment and early retention. Vox Sang. 2015 Feb;108(2):178-85. doi: 10.1111/vox.12210. Epub 2014 Dec 3. |