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

Yasoo Health

Status and phase: Completed; Phase 3; Phase 2

Conditions: Bariatric Surgery Candidate

Treatments: 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

Funder types: Industry

Identifiers

NCT01475617

AQV-001

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Novel Multivitamin/Mineral Supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: AquaVanta Chewable Tablet

Dietary Supplement: Nature Made Calcium Softgels

Dietary Supplement: Nature Made Calcium Softgels

Standard of care supplement

Active Comparator group

Description:

These subjects will be given the standard recommended regimen at Johns Hopkins Bayview Medical Center post RYGB bariatric surgery for 6 months duration.

Treatment:

Dietary Supplement: Twin Labs Iron Caps

Dietary Supplement: Rexall Vitamin B12 Tablet

Dietary Supplement: Nature Made Calcium Softgels

Dietary Supplement: Flinstones Complete

Dietary Supplement: Nature Made Calcium Softgels