Trial | NCT01609387  Report issue

Title

Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)
Postoperative Vitamin Supplementation in Morbidly Obese Patient

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    300
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.
Study Started
Jul 31
2011
Primary Completion
Oct 31
2015
Study Completion
Dec 31
2015
Last Update
May 03
2016
Estimate

Dietary Supplement Fit For me

Dietary Supplement Davitamon

Gastric Banding new vitamins Experimental

Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients)

Gastric Banding current vitamins Active Comparator

Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients)

RYGB new vitamins Experimental

Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients

RYGB current vitamins Active Comparator

Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients)

Gastric sleeve new vitamins Experimental

Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients)

Gastric sleeve current vitamins Active Comparator

Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients)

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
No Results Posted