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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Yasoo Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yasoo Health
ClinicalTrials.gov Identifier:
NCT01475617
First received: November 7, 2011
Last updated: November 16, 2011
Last verified: November 2011

November 7, 2011
November 16, 2011
November 2011
November 2012   (final data collection date for primary outcome measure)
Plasma vitamin and mineral levels [ Time Frame: 3 and 6 months compared to baseline ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01475617 on ClinicalTrials.gov Archive Site
Questionnaire regarding the palatability of the formulation and the ease of administration of the formats and dosing schedule [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of a Novel Multivitamin-Mineral Supplement in Preventing Vitamin Deficiency in Postoperative Bariatric Patients
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Bariatric Surgery Candidate
  • Dietary Supplement: AquaVanta Chewable Tablet
    AquaVanta Chewable Tablet (proprietary formulation of vitamin and minerals) 2 times a day for 6 months
  • Dietary Supplement: Flinstones Complete
    Flinstones Complete Multivitamin 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
  • 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
  • Experimental: Novel Multivitamin/Mineral Supplement
    These subjects will be given a novel multivitamin/mineral supplement post RYGB bariatric surgery for 6 months duration.
    Interventions:
    • Dietary Supplement: AquaVanta Chewable Tablet
    • Dietary Supplement: Nature Made Calcium Softgels
  • 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.
    Interventions:
    • Dietary Supplement: Flinstones Complete
    • Dietary Supplement: Nature Made Calcium Softgels
    • Dietary Supplement: Twin Labs Iron Caps
    • Dietary Supplement: Rexall Vitamin B12 Tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
March 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Shelley Adderley (410) 550-4472 sadderl1@jhmi.edu
United States
 
NCT01475617
AQV-001
No
Yasoo Health
Yasoo Health
Not Provided
Principal Investigator: Kimberley Steele Steele, MD Johns Hopkins University
Yasoo Health
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP