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Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)

Postoperative Vitamin Supplementation in Morbidly Obese Patient

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01609387
Enrollment
300
Registered
2012-06-01
Start date
2011-07-31
Completion date
2015-12-31
Last updated
2016-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Vitamin Deficiency

Keywords

Vitamine, mineral, obese patients, Vitamine en mineral shortage in obese patients

Brief summary

This study is a double blind randomized controlled trial.

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.

Interventions

DIETARY_SUPPLEMENTFit For me
DIETARY_SUPPLEMENTDavitamon

Sponsors

Rijnstate Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Reduction of iron deficiency in obese patientsone year

Secondary

MeasureTime frame
Reduction of vitamin D and vitamin B12 deficiencyone year

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026