Clinical trial NCT01475617: Efficacy of a Novel Multivitamin-Mineral Supplement in Preventing Vitamin Deficiency in Postoperative Bariatric Patients
Official title: Efficacy of a Novel Multivitamin-Mineral Supplement in Preventing Vitamin Deficiency in Postoperative Bariatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bariatric Surgery Candidate
Lead sponsor: Yasoo Health
Sponsor class: INDUSTRY
First posted: 2011-11-21
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: Plasma vitamin and mineral levels
timeFrame: 3 and 6 months compared to baseline
Secondary outcomes:
measure: Questionnaire regarding the palatability of the formulation and the ease of administration of the formats and dosing schedule
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The John's Hopkins Center for Bariatric Surgery (JHCBS)
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kimberley Steele Steele, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perin J, Prokopowicz G, Furtado M, Papas K, Steele KE. A Randomized Trial of a Novel Chewable Multivitamin and Mineral Supplement Following Roux-en-Y Gastric Bypass. Obes Surg. 2018 Aug;28(8):2406-2420. doi: 10.1007/s11695-018-3177-0.