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
  Purpose

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.


Condition Intervention Phase
Bariatric Surgery Candidate
Dietary Supplement: AquaVanta Chewable Tablet
Dietary Supplement: Flinstones Complete
Dietary Supplement: Nature Made Calcium Softgels
Dietary Supplement: Twin Labs Iron Caps
Dietary Supplement: Rexall Vitamin B12 Tablet
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy of a Novel Multivitamin-Mineral Supplement in Preventing Vitamin Deficiency in Postoperative Bariatric Patients

Resource links provided by NLM:


Further study details as provided by Yasoo Health:

Primary Outcome Measures:
  • Plasma vitamin and mineral levels [ Time Frame: 3 and 6 months compared to baseline ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Novel Multivitamin/Mineral Supplement
These subjects will be given a novel multivitamin/mineral supplement post RYGB bariatric surgery for 6 months duration.
Dietary Supplement: AquaVanta Chewable Tablet
AquaVanta Chewable Tablet (proprietary formulation of vitamin and minerals) 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
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.
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475617

Contacts
Contact: Shelley Adderley (410) 550-4472 sadderl1@jhmi.edu

Locations
United States, Maryland
The John's Hopkins Center for Bariatric Surgery (JHCBS) Recruiting
Baltimore, Maryland, United States, 21224-2780
Principal Investigator: Kimberley Steele, MD         
Sponsors and Collaborators
Yasoo Health
Investigators
Principal Investigator: Kimberley Steele Steele, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Yasoo Health
ClinicalTrials.gov Identifier: NCT01475617     History of Changes
Other Study ID Numbers: AQV-001
Study First Received: November 7, 2011
Last Updated: November 16, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcium, Dietary
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014