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Approximately 33% of the US adult population can be classified as obese based on body mass index. This epidemic of obesity has resulted in over 200,000 bariatric surgeries performed every year for the treatment of "clinically severe obesity". Roux-en-Y gastric bypass (RYGB) is the most common bariatric procedure performed in the United States and has both restrictive and malabsorptive components. Despite the success of this procedure in creating long lasting weight loss, vitamin and iron deficiencies are common and can lead to significant morbidity if not appropriately addressed. Despite the American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery Medical Guidelines that include vitamin and mineral supplementation recommendations, there has been very little prospective research conducted to assess the efficacy and compliance of these micronutrient interventions.
This prospective randomized controlled clinical study will evaluate the efficacy of a novel vitamin/mineral supplement in decreasing micronutrient deficiencies in post operative bariatric patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel Multivitamin/Mineral Supplement | Experimental | These subjects will be given a novel multivitamin/mineral supplement post RYGB bariatric surgery for 6 months duration. |
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| Standard of care supplement | Active Comparator | These subjects will be given the standard recommended regimen at Johns Hopkins Bayview Medical Center post RYGB bariatric surgery for 6 months duration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AquaVanta Chewable Tablet | Dietary Supplement | AquaVanta Chewable Tablet (proprietary formulation of vitamin and minerals) 2 times a day for 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma vitamin and mineral levels | 3 and 6 months compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire regarding the palatability of the formulation and the ease of administration of the formats and dosing schedule | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberley Steele Steele, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The John's Hopkins Center for Bariatric Surgery (JHCBS) | Baltimore | Maryland | 21224-2780 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29500675 | Derived | Perin J, Prokopowicz G, Furtado M, Papas K, Steele KE. A Randomized Trial of a Novel Chewable Multivitamin and Mineral Supplement Following Roux-en-Y Gastric Bypass. Obes Surg. 2018 Aug;28(8):2406-2420. doi: 10.1007/s11695-018-3177-0. |
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| Flinstones Complete | Dietary Supplement | Flinstones Complete Multivitamin 2 times a day for 6 months |
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| Nature Made Calcium Softgels | Dietary Supplement | Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months |
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| Nature Made Calcium Softgels | Dietary Supplement | Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months |
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| Twin Labs Iron Caps | Dietary Supplement | Twin Labs Iron Caps (Ferrous Fumarate) 18 mg per day for menstruating women for 6 months |
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| Rexall Vitamin B12 Tablet | Dietary Supplement | Rexall Vitamin B12 Tablet (Cyanocobalamin 500 mcg)per day for 6 months |
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