Efficacy of a Novel Multivitamin-Mineral Supplement in Preventing Vitamin Deficiency in Postoperative Bariatric Patients
Completed · Phase 2/Phase 3
Conditions studied: Bariatric Surgery Candidate
In brief
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.
Key facts
- Study ID
- NCT01475617
- Run by
- Yasoo Health
- People needed
- 61
- Starts
- 2011-11-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2015-01-22
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- The John's Hopkins Center for Bariatric Surgery (JHCBS) — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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