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

September 15, 2011
March 5, 2014
July 2011
July 2015   (final data collection date for primary outcome measure)
Reduction of iron deficiency in obese patients [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01609387 on ClinicalTrials.gov Archive Site
Reduction of vitamin D and vitamin B12 deficiency [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)
Postoperative Vitamin Supplementation in Morbidly Obese Patient

This study is a double blind randomized controlled trial.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Obesity
  • Vitamin Deficiency
  • Dietary Supplement: Fit For me
  • Dietary Supplement: Davitamon
  • Experimental: Gastric Banding new vitamins
    Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients)
    Intervention: 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)
    Intervention: Dietary Supplement: Davitamon
  • Experimental: RYGB new vitamins
    Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients
    Intervention: 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)
    Intervention: 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)
    Intervention: 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)
    Intervention: Dietary Supplement: Davitamon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Netherlands
 
NCT01609387
LTC 745
No
Jens Homan, Rijnstate Hospital
Rijnstate Hospital
Not Provided
Principal Investigator: Frits Berends, MD,PhD Rijnstate Arnhem
Rijnstate Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP