The John's Hopkins Center for Bariatric Surgery (JHCBS)
Baltimore, Maryland, 21224-2780, United States
NCT Number: NCT01475617
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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Notify Me18 year–65 year
All sexes
Interventional
Phase 2 / Phase 3
Baltimore, Maryland, 21224-2780, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AquaVanta Chewable Tablet (proprietary formulation of vitamin and minerals) 2 times a day for 6 months
Flinstones Complete Multivitamin 2 times a day for 6 months
Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months
Twin Labs Iron Caps (Ferrous Fumarate) 18 mg per day for menstruating women for 6 months
Rexall Vitamin B12 Tablet (Cyanocobalamin 500 mcg)per day for 6 months
Time frame: 3 and 6 months compared to baseline
Time frame: 6 months
Yasoo Health
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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