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Multicentre randomized controlled trial to evaluate the optimal treatment for patients who developed an iron deficiency after Roux-en-Y Gastric bypass.
Morbid obesity is worldwide a still growing problem. The number of bariatric procedures are still increasing with 9000 bariatric operations in 2009. The golden standard is the Roux-en-Y Gastric bypass (RYGB). The RYGB ensures an excess weight loss of 60-70% in our hospital.
Unfortunately vitamin and mineral deficiencies are a consequence from RYGB. Iron deficiency occurs in 14-66% in the first two years after surgery. Worldwide there are three most used options of treatment for this: treatment with ferrous fumarate, ferrous gluconate and intravenous injection of Ferinject.
Our goal is to determine which treatment is the most effective to normalize ferritin values in the blood and which treatment is the most cost-effective one after a RYGB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferrous fumarate | Active Comparator | 40 patients receive ferrous fumarate 3 times a day 200mg |
|
| Ferrous gluconate | Active Comparator | 40 patients receive ferrous gluconate 2 times a day 695 mg |
|
| Iron(III)carboxymaltose | Active Comparator | 40 patients receive a single intravenous shot of ferinject |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous fumarate | Drug | treatment with ferrous fumarate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured |
|
| Measure | Description | Time Frame |
|---|---|---|
| normal value serum ferritin | 1 year after initiating therapy | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| patients preference for oral or intravenous therapy | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLVG West/ Sint Lucas Andreas Ziekenhuis | Amsterdam | North Holland | 1061 AE | Netherlands | ||
| Rijnstate hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32402684 | Derived | Schijns W, Boerboom A, de Bruyn Kops M, de Raaff C, van Wagensveld B, Berends FJ, Janssen IMC, van Laarhoven CJHM, de Boer H, Aarts EO. A randomized controlled trial comparing oral and intravenous iron supplementation after Roux-en-Y gastric bypass surgery. Clin Nutr. 2020 Dec;39(12):3779-3785. doi: 10.1016/j.clnu.2020.04.010. Epub 2020 Apr 21. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 8, 2020 | |
| Reset | Jun 25, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 8, 2020 | Jun 25, 2020 |
| 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 |
|---|---|
| C031621 | ferrous fumarate |
| C011819 | ferrous gluconate |
| C522335 | ferric carboxymaltose |
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| Ferrous gluconate | Drug | treatment with ferrous gluconate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured |
|
|
| Iron(III)carboxymaltose | Drug | treatment with Iron(III)carboxymaltose and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured |
|
|
| Arnhem |
| 6800WC |
| Netherlands |
| Rose Kruis Ziekenhuis | Beverwijk | Netherlands |