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Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)

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ClinicalTrials.gov Identifier: NCT01609387
Recruitment Status : Completed
First Posted : June 1, 2012
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Jens Homan, Rijnstate Hospital

Study Description
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Brief Summary:
This study is a double blind randomized controlled trial.

Condition or disease Intervention/treatment Phase
Obesity Vitamin Deficiency Dietary Supplement: Fit For me Dietary Supplement: Davitamon Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Postoperative Vitamin Supplementation in Morbidly Obese Patient
Study Start Date : July 2011
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of iron deficiency in obese patients [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Reduction of vitamin D and vitamin B12 deficiency [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

  1. Creatinine > 150micromol / L
  2. Liver enzymes > 2 times the upper limit
  3. Previous surgery on the gastrointestinal tract
  4. Intercurrerence disease
  5. Gastrointestinal Diseases
  6. Psychiatric illness
  7. Drugs that affect bone metabolism
  8. Known pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Jens Homan, Investigator, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT01609387     History of Changes
Other Study ID Numbers: LTC 745
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: May 2016

Keywords provided by Jens Homan, Rijnstate Hospital:
Vitamine
mineral
obese patients
Vitamine en mineral shortage in obese patients

Additional relevant MeSH terms:
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Tocopherols
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents