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

Phase 2

Completed

• Conditions: Bariatric Surgery Candidate
• Interventions: Dietary Supplement: Flinstones Complete; Dietary Supplement: AquaVanta Chewable Tablet; Dietary Supplement: Nature Made Calcium Softgels; Dietary Supplement: Twin Labs Iron Caps; Dietary Supplement: Rexall Vitamin B12 Tablet

• Registration Number: NCT01475617
• Lead Sponsor: Yasoo Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-07
• Study First Submitted QC: 2011-11-16
• Study First Posted: 2011-11-21
• Primary Completion: 2014-01
• Study Completion: 2014-06
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-20
• Last Update Posted: 2015-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novel Multivitamin/Mineral Supplement	Nature Made Calcium Softgels	These subjects will be given a novel multivitamin/mineral supplement post RYGB bariatric surgery for 6 months duration.
Standard of care supplement	Nature Made Calcium Softgels	These subjects will be given the standard recommended regimen at Johns Hopkins Bayview Medical Center post RYGB bariatric surgery for 6 months duration.
Standard of care supplement	Flinstones Complete	These subjects will be given the standard recommended regimen at Johns Hopkins Bayview Medical Center post RYGB bariatric surgery for 6 months duration.
Novel Multivitamin/Mineral Supplement	AquaVanta Chewable Tablet	These subjects will be given a novel multivitamin/mineral supplement post RYGB bariatric surgery for 6 months duration.
Standard of care supplement	Rexall Vitamin B12 Tablet	These subjects will be given the standard recommended regimen at Johns Hopkins Bayview Medical Center post RYGB bariatric surgery for 6 months duration.
Standard of care supplement	Twin Labs Iron Caps	These subjects will be given the standard recommended regimen at Johns Hopkins Bayview Medical Center post RYGB bariatric surgery for 6 months duration.

Primary Outcome Measures

Name	Time	Method
Plasma vitamin and mineral levels	3 and 6 months compared to baseline

Secondary Outcome Measures

Name	Time	Method
Questionnaire regarding the palatability of the formulation and the ease of administration of the formats and dosing schedule	6 months

Trial Locations

Locations (1)

The John's Hopkins Center for Bariatric Surgery (JHCBS); 🇺🇸 Baltimore, Maryland, United States