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Completed

NCT Number: NCT01609387

Postoperative Vitamin Supplementation in Morbidly Obese Patient (VITAAL Study)

This study is a double blind randomized controlled trial.

Completed

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Key information

Conditions

Obesity Avitaminosis Body Weight Calcinosis Calcium Metabolism Disorders Deficiency Diseases Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vitamin Deficiency

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rijnstate Hospital

Arnhem, Wagnerlaan 55, 6815 AD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fit For me

Dietary Supplement

Davitamon

Dietary Supplement

Primary outcomes

  1. Reduction of iron deficiency in obese patients

    Time frame: one year

Secondary outcomes

  1. Reduction of vitamin D and vitamin B12 deficiency

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

Postoperative Vitamin Supplementation in Morbidly Obese Patient

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 1, 2012
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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