Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)

Rijnstate Hospital300 enrolled

Overview

This study is a double blind randomized controlled trial.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

300

Conditions

Obesity Vitamin Deficiency

Interventions

Fit For meDIETARY_SUPPLEMENT

DavitamonDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rijnstate Hospital

Arnhem, Wagnerlaan 55, Netherlands

Outcomes

Primary Outcomes

Reduction of iron deficiency in obese patients

Time frame: one year

Secondary Outcomes

Reduction of vitamin D and vitamin B12 deficiency

Time frame: one year

Data from ClinicalTrials.gov

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