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This study is a double blind randomized controlled trial.
Based on evidence-based literature on vitamins and minerals, there is a cooperation of a manufacturer multivitamin specifically designed for patients with a gastric band and Roux-en-Y gastric bypass (RYGB). These preparations are the proportions adjusted so that the risk of shortages should decrease and on the other hand, excessive levels of nutrients should be avoided. Main objective of this study is to examine whether these new supplements in particular the number of deficiencies in iron, vitamin B12 and vitamin D can be reduced.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric Banding new vitamins | Experimental | Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients) |
|
| Gastric Banding current vitamins | Active Comparator | Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients) |
|
| RYGB new vitamins | Experimental | Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients |
|
| RYGB current vitamins | Active Comparator | Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients) |
|
| Gastric sleeve new vitamins | Experimental | Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fit For me | Dietary Supplement |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of iron deficiency in obese patients | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of vitamin D and vitamin B12 deficiency | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frits Berends, MD,PhD | Rijnstate Arnhem | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | Wagnerlaan 55 | 6815 AD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31776782 | Derived | Heusschen L, Schijns W, Ploeger N, Deden LN, Hazebroek EJ, Berends FJ, Aarts EO. The True Story on Deficiencies After Sleeve Gastrectomy: Results of a Double-Blind RCT. Obes Surg. 2020 Apr;30(4):1280-1290. doi: 10.1007/s11695-019-04252-1. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D001361 | Avitaminosis |
| D002114 | Calcinosis |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D024505 | Tocopherols |
| ID | Term |
|---|---|
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Gastric sleeve current vitamins | Active Comparator | Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients) |
|
| Davitamon |
| Dietary Supplement |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |