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OpenTrials
Completed

NCT Number: NCT01475617

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Baltimore, Maryland, 21224-2780, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AquaVanta Chewable Tablet

Dietary Supplement

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

Flinstones Complete

Dietary Supplement

Flinstones Complete Multivitamin 2 times a day for 6 months

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

Twin Labs Iron Caps

Dietary Supplement

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

Rexall Vitamin B12 Tablet

Dietary Supplement

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

Primary outcomes

  1. Plasma vitamin and mineral levels

    Time frame: 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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Yasoo Health

Industry

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 21, 2011
Registry last updated
Jan 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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