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| Name | Class |
|---|---|
| Institute for Transfusion Medicine | UNKNOWN |
| Versiti Blood Health | OTHER |
| Blood Centers of the Pacific | UNKNOWN |
| American National Red Cross |
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The purpose of this study is to investigate the effect of daily iron supplements after blood donation on time to recovery of hemoglobin and iron stores. The study will also determine whether the effect of iron supplements on time to recovery is different in men and women, in older vs. younger donors (<60 years old vs. at least 60 years old) and in donors with replete vs. diminished pre-donation iron stores.
The effect of taking iron supplements after blood donation on time to recovery of hemoglobin has been documented but it is not clear whether the benefits of iron supplements vary with age, gender or iron stores. To study this issue, individuals who are eligible to donate blood, based on hemoglobin level, will be randomized to receive daily iron supplements or no supplements. Randomization will be stratified on gender (male or female), age (<60 years old vs. at least 60 years old) and iron status (serum ferritin >26 vs serum ferritin no greater than 26). Subjects will be followed for 24 weeks with periodic blood draws to determine time to recovery of hemoglobin and iron stores. A 7 ml (about 1.5 teaspoons) blood sample will be drawn at each of seven study visits over the 24 weeks to track recovery of hemoglobin and iron.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron supplements | Experimental | Subjects who are randomized to receive daily iron supplements after donating blood |
|
| Control | No Intervention | Subjects who are randomized not to receive daily iron supplements after donating blood |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ferrous gluconate | Dietary Supplement | daily capsule of ferrous gluconate containing 38 mg of elemental iron |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to recovery of hemoglobin after blood donation | Hemoglobin will be measured 3-7 days and 2, 4, 8, 12, 16 and 24 weeks after blood donation. A nonlinear regression of hemoglobin vs time since donation will be used to determine time to recovery of hemoglobin to 80% of the pre-donation level. | Up to 24 weeks after blood donation |
| Measure | Description | Time Frame |
|---|---|---|
| Iron stores | Ferritin will be measured 3-7 days and 2, 4, 8, 12, 16 and 24 weeks after blood donation. A nonlinear regression of hemoglobin vs time since donation will be used to determine time to recovery of to pre-donation iron stores. | Up to 24 weeks after blood donation |
| Total body iron |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joe Kiss, MD | Institute for Transfusion Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blood Centers of the Pacific | San Francisco | California | 94118 | United States | ||
| American Red Cross, Connecticut Region |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32243609 | Derived | Mast AE, Szabo A, Stone M, Cable RG, Spencer BR, Kiss JE; NHLBI Recipient Epidemiology Donor Evaluation Study (REDS)-III. The benefits of iron supplementation following blood donation vary with baseline iron status. Am J Hematol. 2020 Jul;95(7):784-791. doi: 10.1002/ajh.25800. Epub 2020 Apr 15. | |
| 27232535 | Derived |
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| ID | Term |
|---|---|
| C011819 | ferrous gluconate |
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| OTHER |
| University of California, San Francisco | OTHER |
| Vitalant Research Institute | OTHER |
| RTI International | OTHER |
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Soluble transferrin receptor (sTfR) in blood will be measured 3-7 days and 24 weeks after blood donation. The ratio of sTfR to ferritin will provide a measure of total body iron at the two time points. Recovery of total body iron will be estimated from the difference between the ratios at the two time points. |
| 24 weeks after blood donation |
| Farmington |
| Connecticut |
| 06032 |
| United States |
| Institute for Transfusion Medicine | Pittsburgh | Pennsylvania | 15213 | United States |
| Blood Center of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Cable RG, Brambilla D, Glynn SA, Kleinman S, Mast AE, Spencer BR, Stone M, Kiss JE; National Heart, Lung, and Blood Institute Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). Effect of iron supplementation on iron stores and total body iron after whole blood donation. Transfusion. 2016 Aug;56(8):2005-12. doi: 10.1111/trf.13659. Epub 2016 May 27. |
| 25668261 | Derived | Kiss JE, Brambilla D, Glynn SA, Mast AE, Spencer BR, Stone M, Kleinman SH, Cable RG; National Heart, Lung, and Blood Institute (NHLBI) Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). Oral iron supplementation after blood donation: a randomized clinical trial. JAMA. 2015 Feb 10;313(6):575-83. doi: 10.1001/jama.2015.119. |