Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)
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ClinicalTrials.gov Identifier: NCT01609387 |
Recruitment Status
:
Completed
First Posted
: June 1, 2012
Last Update Posted
: May 3, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity Vitamin Deficiency | Dietary Supplement: Fit For me Dietary Supplement: Davitamon | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Postoperative Vitamin Supplementation in Morbidly Obese Patient |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | October 2015 |
Actual Study Completion Date : | December 2015 |
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 |
- Reduction of iron deficiency in obese patients [ Time Frame: one year ]
- Reduction of vitamin D and vitamin B12 deficiency [ Time Frame: one year ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609387
Netherlands | |
Rijnstate Hospital | |
Arnhem, Wagnerlaan 55, Netherlands, 6815 AD |
Principal Investigator: | Frits Berends, MD,PhD | Rijnstate Arnhem |
Responsible Party: | Jens Homan, Investigator, Rijnstate Hospital |
ClinicalTrials.gov Identifier: | NCT01609387 History of Changes |
Other Study ID Numbers: |
LTC 745 |
First Posted: | June 1, 2012 Key Record Dates |
Last Update Posted: | May 3, 2016 |
Last Verified: | May 2016 |
Keywords provided by Jens Homan, 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 |