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

NCT01475617 | Completed Phase 2

• 1 other identifier: AQV-001
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• Plasma vitamin and mineral levels

  3 and 6 months compared to baseline

Secondary Outcomes (1)

• Questionnaire regarding the palatability of the formulation and the ease of administration of the formats and dosing schedule

  6 months

Study Arms (2)

Novel Multivitamin/Mineral Supplement

EXPERIMENTAL

These subjects will be given a novel multivitamin/mineral supplement post RYGB bariatric surgery for 6 months duration.

Dietary Supplement: AquaVanta Chewable Tablet; Dietary Supplement: Nature Made Calcium Softgels

Standard of care supplement

ACTIVE COMPARATOR

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; Dietary Supplement: Nature Made Calcium Softgels; Dietary Supplement: Twin Labs Iron Caps; Dietary Supplement: Rexall Vitamin B12 Tablet

Interventions

AquaVanta Chewable Tablet DIETARY_SUPPLEMENT

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

Novel Multivitamin/Mineral Supplement

Flinstones Complete DIETARY_SUPPLEMENT

Flinstones Complete Multivitamin 2 times a day for 6 months

Standard of care supplement

Nature Made Calcium Softgels DIETARY_SUPPLEMENT

Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months

Novel Multivitamin/Mineral Supplement

Twin Labs Iron Caps DIETARY_SUPPLEMENT

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

Standard of care supplement

Rexall Vitamin B12 Tablet DIETARY_SUPPLEMENT

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

Standard of care supplement

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yasoo Health: lead

Study Sites (1)

The John's Hopkins Center for Bariatric Surgery (JHCBS)

Baltimore, Maryland, 21224-2780, United States

Location

Related Publications (1)

• 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.

  PMID: 29500675 DERIVED

Study Officials

• Kimberley Steele Steele, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 21, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 22, 2015

Record last verified: 2015-01

Locations

US (1)