Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)

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

Detailed Description
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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.

Official Title
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Postoperative Vitamin Supplementation in Morbidly Obese Patient

Conditions
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Obesity, Vitamin Deficiency

Intervention / Treatment
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* Dietary Supplement: Fit For me
* Dietary Supplement: Davitamon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastric Banding new vitamins<br>Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients) | Dietary Supplement: Fit For me<br> <br> |
| Active Comparator: Gastric Banding current vitamins<br>Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients) | Dietary Supplement: Davitamon<br> <br> |
| Experimental: RYGB new vitamins<br>Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients | Dietary Supplement: Fit For me<br> <br> |
| Active Comparator: RYGB current vitamins<br>Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients) | Dietary Supplement: Davitamon<br> <br> |
| Experimental: Gastric sleeve new vitamins<br>Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients) | Dietary Supplement: Fit For me<br> <br> |
| Active Comparator: Gastric sleeve current vitamins<br>Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients) | Dietary Supplement: Davitamon<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of iron deficiency in obese patients |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of vitamin D and vitamin B12 deficiency |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamine, mineral, obese patients, Vitamine en mineral shortage in obese patients