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

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475617
• Other study ID #: AQV-001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 7, 2011
• Last updated: January 20, 2015
• Start date: November 2011
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: Yasoo Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Avitaminosis
• Bariatric Surgery Candidate

Intervention

Dietary Supplement:
• AquaVanta Chewable Tablet
AquaVanta Chewable Tablet (proprietary formulation of vitamin and minerals) 2 times a day for 6 months
• Flinstones Complete
Flinstones Complete Multivitamin 2 times a day for 6 months
• Nature Made Calcium Softgels
Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months
• Nature Made Calcium Softgels
Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months
• Twin Labs Iron Caps
Twin Labs Iron Caps (Ferrous Fumarate) 18 mg per day for menstruating women for 6 months
• Rexall Vitamin B12 Tablet
Rexall Vitamin B12 Tablet (Cyanocobalamin 500 mcg)per day for 6 months

Locations

Country	Name	City	State
United States	The John's Hopkins Center for Bariatric Surgery (JHCBS)	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Yasoo Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma vitamin and mineral levels		3 and 6 months compared to baseline	Yes
Secondary	Questionnaire regarding the palatability of the formulation and the ease of administration of the formats and dosing schedule		6 months	No