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2 different oral iron supplementations after blood donation are compared.
Iron depletion is common in regular blood donors. During a blood donation the donor loses 200-250 mg iron. The routine at our donor sites is to give donors 20 tablets of iron sulphate (Duroferon®) 100 mg after blood donation.
In this study we will compare two different iron supplementations given after blood donation. 60 donors are given oral sucrosomial Iron (SiderAl Forte®) and 60 donors are given oral iron sulphate (Duroferon®) after 4 successive blood donation.
The primary purpose of this study is to compare the side effects of sucrosomial Iron and iron sulphate and to investigate if the iron balance can be maintained with sucrosomial iron.
After each blood donation the donors are asked to answer a questionary with questions about side effects and symptoms of Restless legs syndrome/Willis-Ekbom (symptoms associated with iron deficiency).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral sucrosomial Iron (SiderAl Forte®) | Experimental | Oral sucrosomial Iron (SiderAl Forte®) is given to blood donors after blood donation |
|
| Oral iron sulphate (Duroferon®) | Active Comparator | Oral iron sulphate (Duroferon®) is given to blood donors after blood donation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sucrosomial Iron | Drug | 20 capsules of Sucrosomial Iron 30 mg is given after blood donation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | The side effects are compared. At every visit the donors are asked to answer a questionary with questions about side effects. The amount and severity of the side effects will be compared between the two groups with different iron supplementations. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms | Symptoms of Restless legs syndrome/Willis-Ekbom syndrom. At every visit the donors are asked to answer a questionary with questions about symptoms of restless legs. The amount and severity of the symptoms of the two groups with different iron supplementations will be compared. | One year |
| Iron balance |
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Inclusion Criteria:
Blood donors at Uppsala University hospital wo have been donating blood regularly the last two years are eligible to participate in the study.
Exclusion Criteria:
Donors who cannot be accepted for blood donation anymore because they do not fulfill the Swedish criteria for blood donation.
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| Name | Affiliation | Role |
|---|---|---|
| Norbert Lubenow, PhD | Clinical Immunology and Transfusion Medicine Uppsala University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Immunology and Transfusion Medicine, Uppsala University Hospital | Uppsala | 75237 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30287781 | Background | Gomez-Ramirez S, Brilli E, Tarantino G, Munoz M. Sucrosomial(R) Iron: A New Generation Iron for Improving Oral Supplementation. Pharmaceuticals (Basel). 2018 Oct 4;11(4):97. doi: 10.3390/ph11040097. | |
| 30213039 | Background | Fabiano A, Brilli E, Mattii L, Testai L, Moscato S, Citi V, Tarantino G, Zambito Y. Ex Vivo and in Vivo Study of Sucrosomial(R) Iron Intestinal Absorption and Bioavailability. Int J Mol Sci. 2018 Sep 12;19(9):2722. doi: 10.3390/ijms19092722. |
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Only aggregated data will be shared.
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| ID | Term |
|---|---|
| C000718012 | sucrosomial iron |
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
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Drugs:
Oral sucrosomial Iron (SiderAl Forte®) and oral iron sulphate (Duroferon®) to blood donors
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| Iron Sulfate | Drug | 20 tablets of oral iron sulphate (Duroferon®) 100 mg is given after blood donation |
|
|
Laboratory analyzes |
| One Year |
| 20598107 | Background | Birgegard G, Schneider K, Ulfberg J. High incidence of iron depletion and restless leg syndrome (RLS) in regular blood donors: intravenous iron sucrose substitution more effective than oral iron. Vox Sang. 2010 Nov;99(4):354-61. doi: 10.1111/j.1423-0410.2010.01368.x. |
| 25395392 | Background | Pisani A, Riccio E, Sabbatini M, Andreucci M, Del Rio A, Visciano B. Effect of oral liposomal iron versus intravenous iron for treatment of iron deficiency anaemia in CKD patients: a randomized trial. Nephrol Dial Transplant. 2015 Apr;30(4):645-52. doi: 10.1093/ndt/gfu357. Epub 2014 Nov 13. |
| 25700159 | Background | Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015. |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |