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NCT01475617 · ClinicalTrials.gov registry record · Phase 2
Efficacy of a Novel Multivitamin-Mineral Supplement in Preventing Vitamin Deficiency in Postoperative Bariatric Patients
A Phase 2 study of Bariatric Surgery Candidate, sponsored by Yasoo Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 1
- Study location
NCT01475617: Completed Phase 2 study of Bariatric Surgery Candidate, sponsored by Yasoo Health.
NCT01475617 is a Phase 2 study of Bariatric Surgery Candidate that has completed, run by Yasoo Health. The registered enrollment target is 61 participants, below the 111-participant average among 28 other Bariatric Surgery Candidate trials with a reported enrollment target (45% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01475617, a Phase 2 study of Bariatric Surgery Candidate, has completed, sponsored by Yasoo Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT AquaVanta Chewable Tablet
- DIETARY_SUPPLEMENT Flinstones Complete
- DIETARY_SUPPLEMENT Nature Made Calcium Softgels
- DIETARY_SUPPLEMENT Twin Labs Iron Caps
Study Locations (1)
Maryland
- The John's Hopkins Center for Bariatric Surgery (JHCBS) - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
What the finished NCT01475617 record still lists
NCT01475617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 111-participant average among 28 other Bariatric Surgery Candidate trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Bariatric Surgery Candidate appearing as the primary indexed condition, and to 4 interventions - of which AquaVanta Chewable Tablet is the first listed.
NCT01475617 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01475617 about?
NCT01475617 is a clinical study titled "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 bariat...
What is the current status of trial NCT01475617?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2011-11. Estimated completion is 2014-06.
What conditions does trial NCT01475617 study?
This clinical trial studies the following conditions: Bariatric Surgery Candidate.
What interventions are being tested in trial NCT01475617?
The interventions under investigation include: AquaVanta Chewable Tablet (DIETARY_SUPPLEMENT), Flinstones Complete (DIETARY_SUPPLEMENT), Nature Made Calcium Softgels (DIETARY_SUPPLEMENT), Twin Labs Iron Caps (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01475617?
This trial is sponsored by Yasoo Health, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01475617 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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participants (enrollment target), bucketed by value
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