Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)
This study is ongoing, but not recruiting participants.
Sponsor:
Rijnstate Hospital
Information provided by (Responsible Party):
Jens Homan, Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT01609387
First received: September 15, 2011
Last updated: August 13, 2014
Last verified: August 2014
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Purpose
This study is a double blind randomized controlled trial.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity Vitamin Deficiency |
Dietary Supplement: Fit For me Dietary Supplement: Davitamon |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Postoperative Vitamin Supplementation in Morbidly Obese Patient |
Further study details as provided by Rijnstate Hospital:
Primary Outcome Measures:
- Reduction of iron deficiency in obese patients [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Reduction of vitamin D and vitamin B12 deficiency [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 450 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gastric Banding new vitamins
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients)
|
Dietary Supplement: Fit For me |
|
Active Comparator: Gastric Banding current vitamins
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients)
|
Dietary Supplement: Davitamon |
|
Experimental: RYGB new vitamins
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients
|
Dietary Supplement: Fit For me |
|
Active Comparator: RYGB current vitamins
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients)
|
Dietary Supplement: Davitamon |
|
Experimental: Gastric sleeve new vitamins
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients)
|
Dietary Supplement: Fit For me |
|
Active Comparator: Gastric sleeve current vitamins
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients)
|
Dietary Supplement: Davitamon |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients on the waiting list for RYGB or gastric band and meets
- Age between 18-65 years
Exclusion Criteria:
- Creatinine > 150micromol / L
- Liver enzymes > 2 times the upper limit
- Previous surgery on the gastrointestinal tract
- Intercurrerence disease
- Gastrointestinal Diseases
- Psychiatric illness
- Drugs that affect bone metabolism
- Known pregnancy
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609387
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609387
Locations
| Netherlands | |
| Rijnstate Hospital | |
| Arnhem, Wagnerlaan 55, Netherlands, 6815 AD | |
Sponsors and Collaborators
Rijnstate Hospital
Investigators
| Principal Investigator: | Frits Berends, MD,PhD | Rijnstate Arnhem |
More Information
No publications provided
| Responsible Party: | Jens Homan, Investigator, Rijnstate Hospital |
| ClinicalTrials.gov Identifier: | NCT01609387 History of Changes |
| Other Study ID Numbers: | LTC 745 |
| Study First Received: | September 15, 2011 |
| Last Updated: | August 13, 2014 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Rijnstate Hospital:
|
Vitamine mineral obese patients Vitamine en mineral shortage in obese patients |
Additional relevant MeSH terms:
|
Vitamins Growth Substances Micronutrients Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015