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Efficacy of a Novel Multivitamin-Mineral Supplement in Preventing Vitamin Deficiency in Postoperative Bariatric Patients
NCT01475617 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01475617
The ClinicalTrials.gov registry entry for NCT01475617 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yasoo Health, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01475617 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01475617?
This trial is sponsored by Yasoo Health, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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