Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)
This study is currently recruiting participants.
Verified May 2012 by Rijnstate Hospital
Sponsor:
Rijnstate Hospital
Information provided by (Responsible Party):
Parweez Koehestanie, Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT01609387
First received: September 15, 2011
Last updated: May 29, 2012
Last verified: May 2012
| Tracking Information | |||||
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| First Received Date ICMJE | September 15, 2011 | ||||
| Last Updated Date | May 29, 2012 | ||||
| Start Date ICMJE | July 2011 | ||||
| Estimated Primary Completion Date | July 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Reduction of iron deficiency in obese patients [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01609387 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Reduction of vitamin D and vitamin B12 deficiency [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study) | ||||
| Official Title ICMJE | Postoperative Vitamin Supplementation in Morbidly Obese Patient | ||||
| Brief Summary | This study is a double blind randomized controlled trial. |
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| Detailed Description | Based on evidence-based literature on vitamins and minerals, there is a cooperation of a manufacturer multivitamin specifically designed for patients with a gastric band and Roux-en-Y gastric bypass (RYGB). These preparations are the proportions adjusted so that the risk of shortages should decrease and on the other hand, excessive levels of nutrients should be avoided. Main objective of this study is to examine whether these new supplements in particular the number of deficiencies in iron, vitamin B12 and vitamin D can be reduced. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 450 | ||||
| Estimated Completion Date | July 2015 | ||||
| Estimated Primary Completion Date | July 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01609387 | ||||
| Other Study ID Numbers ICMJE | LTC 745 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Parweez Koehestanie, Rijnstate Hospital | ||||
| Study Sponsor ICMJE | Rijnstate Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Rijnstate Hospital | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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