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

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Dietary supplement: AquaVanta Chewable Tablet; Dietary supplement: Nature Made Calcium Softgels; Dietary supplement: Flinstones Complete; Dietary supplement: Twin Labs Iron Caps; Dietary supplement: Rexall Vitamin B12 Tablet

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224-2780
      • The John's Hopkins Center for Bariatric Surgery (JHCBS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novel Multivitamin/Mineral Supplement; These subjects will be given a novel multivitamin/mineral supplement post RYGB bariatric surgery for 6 months duration.	Dietary supplement: AquaVanta Chewable Tablet; AquaVanta Chewable Tablet (proprietary formulation of vitamin and minerals) 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
Active Comparator: Standard of care supplement; 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: 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: Flinstones Complete; Flinstones Complete Multivitamin 2 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yasoo Health
• Investigators: Principal Investigator: Kimberley Steele Steele, MD, Johns Hopkins University

Publications and helpful links

General Publications

• Perin J, Prokopowicz G, Furtado M, Papas K, Steele KE. A Randomized Trial of a Novel Chewable Multivitamin and Mineral Supplement Following Roux-en-Y Gastric Bypass. Obes Surg. 2018 Aug;28(8):2406-2420. doi: 10.1007/s11695-018-3177-0.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: November 7, 2011
• First Submitted That Met QC Criteria: November 16, 2011
• First Posted (Estimate): November 21, 2011

Study Record Updates

• Last Update Posted (Estimate): January 22, 2015
• Last Update Submitted That Met QC Criteria: January 20, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Deficiency Diseases; Malnutrition; Avitaminosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin B Complex; Hematinics; Calcium; Vitamin B 12; Hydroxocobalamin; Calcium, Dietary
• Other Study ID Numbers: AQV-001