Efficacy of a Novel Multivitamin-Mineral Supplement in Preventing Vitamin Deficiency in Postoperative Bariatric Patients

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of a Novel Multivitamin-Mineral Supplement in Preventing Vitamin Deficiency in Postoperative Bariatric Patients

Conditions
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Bariatric Surgery Candidate

Intervention / Treatment
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* Dietary Supplement: AquaVanta Chewable Tablet
* Dietary Supplement: Flinstones Complete
* Dietary Supplement: Nature Made Calcium Softgels
* Dietary Supplement: Nature Made Calcium Softgels
* Dietary Supplement: Twin Labs Iron Caps
* Dietary Supplement: Rexall Vitamin B12 Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novel Multivitamin/Mineral Supplement<br>These subjects will be given a novel multivitamin/mineral supplement post RYGB bariatric surgery for 6 months duration. | Dietary Supplement: AquaVanta Chewable Tablet<br>* AquaVanta Chewable Tablet (proprietary formulation of vitamin and minerals) 2 times a day for 6 months<br>Dietary Supplement: Nature Made Calcium Softgels<br>* Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months<br>|
| Active Comparator: Standard of care supplement<br>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<br>* Flinstones Complete Multivitamin 2 times a day for 6 months<br>Dietary Supplement: Nature Made Calcium Softgels<br>* Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months<br>Dietary Supplement: Twin Labs Iron Caps<br>* Twin Labs Iron Caps (Ferrous Fumarate) 18 mg per day for menstruating women for 6 months<br>Dietary Supplement: Rexall Vitamin B12 Tablet<br>* Rexall Vitamin B12 Tablet (Cyanocobalamin 500 mcg)per day for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma vitamin and mineral levels |  | 3 and 6 months compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire regarding the palatability of the formulation and the ease of administration of the formats and dosing schedule |  | 6 months |