Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)
1 other identifier
interventional
300
1 country
1
Brief Summary
This study is a double blind randomized controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 obesity
Started Jul 2011
Longer than P75 for phase_4 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 15, 2011
CompletedFirst Posted
Study publicly available on registry
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMay 3, 2016
May 1, 2016
4.3 years
September 15, 2011
May 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of iron deficiency in obese patients
one year
Secondary Outcomes (1)
Reduction of vitamin D and vitamin B12 deficiency
one year
Study Arms (6)
Gastric Banding new vitamins
EXPERIMENTALRandomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients)
Gastric Banding current vitamins
ACTIVE COMPARATORRandomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients)
RYGB new vitamins
EXPERIMENTALRandomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients
RYGB current vitamins
ACTIVE COMPARATORRandomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients)
Gastric sleeve new vitamins
EXPERIMENTALRandomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients)
Gastric sleeve current vitamins
ACTIVE COMPARATORRandomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients)
Interventions
Eligibility Criteria
You may qualify if:
- Patients on the waiting list for RYGB or gastric band and meets
- Age between 18-65 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rijnstate Hospital
Arnhem, Wagnerlaan 55, 6815 AD, Netherlands
Related Publications (1)
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.
PMID: 31776782DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frits Berends, MD,PhD
Rijnstate Arnhem
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
September 15, 2011
First Posted
June 1, 2012
Study Start
July 1, 2011
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
May 3, 2016
Record last verified: 2016-05