Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)

May 2, 2016 updated by: Jens Homan, Rijnstate Hospital

Postoperative Vitamin Supplementation in Morbidly Obese Patient

This study is a double blind randomized controlled trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Wagnerlaan 55
      • Arnhem, Wagnerlaan 55, Netherlands, 6815 AD
        • Rijnstate Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of iron deficiency in obese patients
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction of vitamin D and vitamin B12 deficiency
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Investigators

  • Principal Investigator: Frits Berends, MD,PhD, Rijnstate Arnhem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 15, 2011

First Submitted That Met QC Criteria

May 29, 2012

First Posted (Estimate)

June 1, 2012

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTC 745

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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