Efficacy of a Novel Multivitamin-Mineral Supplement in Preventing Vitamin Deficiency in Postoperative Bariatric Patients
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.
|Bariatric Surgery Candidate||Dietary Supplement: AquaVanta Chewable Tablet Dietary Supplement: Flinstones Complete Dietary Supplement: Nature Made Calcium Softgels Dietary Supplement: Twin Labs Iron Caps Dietary Supplement: Rexall Vitamin B12 Tablet||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Efficacy of a Novel Multivitamin-Mineral Supplement in Preventing Vitamin Deficiency in Postoperative Bariatric Patients|
- Plasma vitamin and mineral levels [ Time Frame: 3 and 6 months compared to baseline ]
- Questionnaire regarding the palatability of the formulation and the ease of administration of the formats and dosing schedule [ Time Frame: 6 months ]
|Study Start Date:||November 2011|
|Study Completion Date:||June 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: Novel Multivitamin/Mineral Supplement
These subjects will be given a novel multivitamin/mineral supplement post RYGB bariatric surgery for 6 months duration.
Dietary Supplement: AquaVanta Chewable Tablet
AquaVanta Chewable Tablet (proprietary formulation of vitamin and minerals) 2 times a day for 6 monthsDietary Supplement: Nature Made Calcium Softgels
Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months
Active Comparator: Standard of care supplement
These subjects will be given the standard recommended regimen at Johns Hopkins Bayview Medical Center post RYGB bariatric surgery for 6 months duration.
Dietary Supplement: Flinstones Complete
Flinstones Complete Multivitamin 2 times a day for 6 monthsDietary Supplement: Nature Made Calcium Softgels
Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 monthsDietary Supplement: Twin Labs Iron Caps
Twin Labs Iron Caps (Ferrous Fumarate) 18 mg per day for menstruating women for 6 monthsDietary Supplement: Rexall Vitamin B12 Tablet
Rexall Vitamin B12 Tablet (Cyanocobalamin 500 mcg)per day for 6 months
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475617
|United States, Maryland|
|The John's Hopkins Center for Bariatric Surgery (JHCBS)|
|Baltimore, Maryland, United States, 21224-2780|
|Principal Investigator:||Kimberley Steele Steele, MD||Johns Hopkins University|