Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Rijnstate Hospital
Sponsor:
Information provided by (Responsible Party):
Jens Homan, Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT01609387
First received: September 15, 2011
Last updated: March 5, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


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: July 2015
Estimated Primary Completion Date: July 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:

  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
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

Locations
Netherlands
Rijnstate Hospital Recruiting
Arnhem, Wagnerlaan 55, Netherlands, 6815 AD
Contact: Jens Homan, MD    088 - 005 3567 ext 0031    jhoman@rijnstate.nl   
Contact: Nadine Ploeger       nploeger@rijnstate.nl   
Principal Investigator: Frits Berends, MD.PhD         
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: March 5, 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:
Obesity
Avitaminosis
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Deficiency Diseases
Malnutrition
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014