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Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)

Primary Purpose

Obesity, Vitamin Deficiency

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Fit For me
Davitamon
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Vitamine, mineral, obese patients, Vitamine en mineral shortage in obese patients

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rijnstate Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Gastric Banding new vitamins

Gastric Banding current vitamins

RYGB new vitamins

RYGB current vitamins

Gastric sleeve new vitamins

Gastric sleeve current vitamins

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Reduction of iron deficiency in obese patients

Secondary Outcome Measures

Reduction of vitamin D and vitamin B12 deficiency

Full Information

First Posted
September 15, 2011
Last Updated
May 2, 2016
Sponsor
Rijnstate Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01609387
Brief Title
Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)
Official Title
Postoperative Vitamin Supplementation in Morbidly Obese Patient
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rijnstate Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a double blind randomized controlled trial.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Vitamin Deficiency
Keywords
Vitamine, mineral, obese patients, Vitamine en mineral shortage in obese patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gastric Banding new vitamins
Arm Type
Experimental
Arm Description
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients)
Arm Title
Gastric Banding current vitamins
Arm Type
Active Comparator
Arm Description
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients)
Arm Title
RYGB new vitamins
Arm Type
Experimental
Arm Description
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients
Arm Title
RYGB current vitamins
Arm Type
Active Comparator
Arm Description
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients)
Arm Title
Gastric sleeve new vitamins
Arm Type
Experimental
Arm Description
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients)
Arm Title
Gastric sleeve current vitamins
Arm Type
Active Comparator
Arm Description
Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients)
Intervention Type
Dietary Supplement
Intervention Name(s)
Fit For me
Intervention Type
Dietary Supplement
Intervention Name(s)
Davitamon
Primary Outcome Measure Information:
Title
Reduction of iron deficiency in obese patients
Time Frame
one year
Secondary Outcome Measure Information:
Title
Reduction of vitamin D and vitamin B12 deficiency
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frits Berends, MD,PhD
Organizational Affiliation
Rijnstate Arnhem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
State/Province
Wagnerlaan 55
ZIP/Postal Code
6815 AD
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
31776782
Citation
Heusschen L, Schijns W, Ploeger N, Deden LN, Hazebroek EJ, Berends FJ, Aarts EO. The True Story on Deficiencies After Sleeve Gastrectomy: Results of a Double-Blind RCT. Obes Surg. 2020 Apr;30(4):1280-1290. doi: 10.1007/s11695-019-04252-1.
Results Reference
derived

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Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)

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