NCT01475617

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

Completed Phase 2/Phase 3 Last updated 20 January 2015

What this trial tests

Phase 2/Phase 3 trial testing AquaVanta Chewable Tablet in Bariatric Surgery Candidate in 61 participants. Completed in 1 June 2014.

Timeline

1 November 2011

Primary endpoint
1 January 2014

1 June 2014

Quick facts

Lead sponsor	Yasoo Health
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	61
Start date	1 November 2011
Primary completion	1 January 2014
Estimated completion	1 June 2014
Sites	1 location across United States

Drugs / interventions tested

• AquaVanta Chewable Tablet
• Flinstones Complete
• Nature Made Calcium Softgels
• Nature Made Calcium Softgels
• Twin Labs Iron Caps
• Rexall Vitamin B12 Tablet

Conditions studied

• Bariatric Surgery Candidate — all drugs for Bariatric Surgery Candidate →

Sponsor

Yasoo Health

Who can join

Adults 18 to 65, any sex, with Bariatric Surgery Candidate. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Plasma vitamin and mineral levels
  Time frame: 3 and 6 months compared to baseline

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Randomized Trial of a Novel Chewable Multivitamin and Mineral Supplement Following Roux-en-Y Gastric Bypass.
   Perin J, Prokopowicz G, Furtado M, Papas K, et al · · 2018 · cited 11× · PMID 29500675 · DOI 10.1007/s11695-018-3177-0