Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)

Rijnstate Hospital

Status and phase: Completed; Phase 4

Conditions: Obesity; Vitamin Deficiency

Treatments: Dietary Supplement: Davitamon; Dietary Supplement: Fit For me

Study type: Interventional

Funder types: Other

Identifiers

NCT01609387

LTC 745

Details and patient eligibility

About

This study is a double blind randomized controlled trial.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 6 patient groups

Gastric Banding new vitamins

Experimental group

Description:

Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients)

Treatment:

Dietary Supplement: Fit For me

Gastric Banding current vitamins

Active Comparator group

Description:

Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Band patients)

Treatment:

Dietary Supplement: Davitamon

RYGB new vitamins

Experimental group

Description:

Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients

Treatment:

Dietary Supplement: Fit For me

RYGB current vitamins

Active Comparator group

Description:

Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in RYGB patients)

Treatment:

Dietary Supplement: Davitamon

Gastric sleeve new vitamins

Experimental group

Description:

Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients)

Treatment:

Dietary Supplement: Fit For me

Gastric sleeve current vitamins

Active Comparator group

Description:

Randomization between optimal multivitamins for bariatric surgery and normal over the counter multivitamins (in Gastric Sleeve patients)

Treatment:

Dietary Supplement: Davitamon