Bariatric Surgery Candidate
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTAquaVanta Chewable Tablet
AquaVanta Chewable Tablet (proprietary formulation of vitamin and minerals) 2 times a day for 6 months
DIETARY_SUPPLEMENTFlinstones Complete
Flinstones Complete Multivitamin 2 times a day for 6 months
DIETARY_SUPPLEMENTNature Made Calcium Softgels
Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months
DIETARY_SUPPLEMENTTwin Labs Iron Caps
Twin Labs Iron Caps (Ferrous Fumarate) 18 mg per day for menstruating women for 6 months
DIETARY_SUPPLEMENTRexall Vitamin B12 Tablet
Rexall Vitamin B12 Tablet (Cyanocobalamin 500 mcg)per day for 6 months
Sponsors
Yasoo Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18 - 65 years of age * Meet appropriate criteria for Roux-en-Y gastric bypass (RYGB) surgery as determined by the Principal Investigator at The John's Hopkins Center for Bariatric Surgery (JHCBS)
Exclusion criteria
* Allergy to a component of the formulations * Recent (last 3 months) use of a dietary supplement other than a standard non-bariatric specific multivitamin supplement * Documented levels of fat-soluble vitamins (A,D,E,K) or iron above the normal range * Pregnant or lactating * Expected poor compliance with medical regimen as assessed by JHCBS clinic care providers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma vitamin and mineral levels | 3 and 6 months compared to baseline |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaire regarding the palatability of the formulation and the ease of administration of the formats and dosing schedule | 6 months |
Countries
United States
Outcome results
None listed