Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study) - Full Text View

Purpose

This study is a double blind randomized controlled trial.

Condition	Intervention	Phase
Obesity Vitamin Deficiency	Dietary Supplement: Fit For me Dietary Supplement: Davitamon	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Postoperative Vitamin Supplementation in Morbidly Obese Patient

Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:

Reduction of iron deficiency in obese patients [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction of vitamin D and vitamin B12 deficiency [ Time Frame: one year ] [ Designated as safety issue: No ]


Enrollment:	300
Study Start Date:	July 2011
Study Completion Date:	December 2015
Primary Completion Date:	October 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609387

Locations


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

Sponsors and Collaborators

Rijnstate Hospital

Investigators


Principal Investigator:	Frits Berends, MD,PhD	Rijnstate Arnhem

More Information


Responsible Party:	Jens Homan, Investigator, Rijnstate Hospital
ClinicalTrials.gov Identifier:	NCT01609387 History of Changes
Other Study ID Numbers:	LTC 745
Study First Received:	September 15, 2011
Last Updated:	May 2, 2016
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Rijnstate Hospital:


Vitamine mineral obese patients Vitamine en mineral shortage in obese patients

Additional relevant MeSH terms:


Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vitamins Tocopherols	Micronutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents

ClinicalTrials.gov processed this record on September 30, 2016