Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)

Obesity Clinical Trial

Official title:

Postoperative Vitamin Supplementation in Morbidly Obese Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609387
• Other study ID #: LTC 745
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2011
• Last updated: May 2, 2016
• Start date: July 2011
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

This study is a double blind randomized controlled trial.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Avitaminosis
• Obesity
• Vitamin Deficiency

Intervention

Dietary Supplement:
• Fit For me

• Davitamon

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Wagnerlaan 55

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of iron deficiency in obese patients		one year	No
Secondary	Reduction of vitamin D and vitamin B12 deficiency		one year	No