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

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.

Conditions

• Bariatric Surgery Candidate

Interventions

DIETARY_SUPPLEMENT

AquaVanta Chewable Tablet

AquaVanta Chewable Tablet (proprietary formulation of vitamin and minerals) 2 times a day for 6 months

DIETARY_SUPPLEMENT

Flinstones Complete

Flinstones Complete Multivitamin 2 times a day for 6 months

DIETARY_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

DIETARY_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

DIETARY_SUPPLEMENT

Twin Labs Iron Caps

Twin Labs Iron Caps (Ferrous Fumarate) 18 mg per day for menstruating women for 6 months

DIETARY_SUPPLEMENT

Rexall Vitamin B12 Tablet

Rexall Vitamin B12 Tablet (Cyanocobalamin 500 mcg)per day for 6 months

Sponsors & Collaborators

• Yasoo Health

  lead INDUSTRY

Principal Investigators

• Kimberley Steele Steele, MD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-30

Primary Completion

2014-01-31

Completion

2014-06-30

Countries

• United States

Study Locations