Vitamin Deficiencies and Suppletion in Morbid Obesity

The purpose of this study is to evaluate the most effective treatment for patients who underwent a Roux-en-Y gastric bypass and developed postoperatively a vitamin B12 deficiency.

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Key information

Conditions

Vitamin B12 Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B 12 Deficiency Vitamin B Deficiency

Age range

18 month–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Rijnstate hospital

Arnhem, 6800WC, Netherlands

About this study

Vitamin B12 deficiency accounts up to 23-64% bariatric surgery. The investigators purpose is to evaluate the most effective treatment for vitamin B12 deficiency in patients who underwent a Roux-en-Y gastric bypass.

Daily oral use of vitamin B12 tablets are may be as effective as vitamin B12 injections.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Vitamin B12 deficiency: <200 pmol/l
Vitamin B12 deficiency 6-12 months after surgery
All patients underwent a Roux-en-Y gastric bypass

Exclusion criteria

Creatin >150micromol/L
Liver enzymes >2 times upper limit
Other bariatric operations
Intercurrent diseases
Gastro-intestinal diseases
Psychiatric disease
Medicines which influences bone density
Pregnancy

Treatment and study plan

Hydroxocobalamin

Drug

patients are treated for 6 months with hydroxocobalamin. Patients will be treated with once a dose of 2000ug, after that treatment will be continued with a dose of 1000ug per 2 months. At timepoint 0, 2, 4 and 6 months after treatment vitamin B12 will be measured. At timepoint 0 and 6 also homocystein and methylmalonic acid will be measured.

FitForMe vitamin B12

Drug

patients are treated for 6 months with a daily dose of 1000ug vitamin B12 tablets. At timepoint 0, 2, 4 and 6 months after treatment vitamin B12 will be measured. At timepoint 0 and 6 also homocystein and methylmalonic acid will be measured.

Primary outcomes

reduction in patients with vitamin B12 deficiency

Time frame: 6 months after initiating therapy

Before starting treatment vitamin B12, homocystein and methylmalonic acid will be measured. Two and 4 months after starting treatment vitamine B12 levels will be measured. At 6 months after initiating therapy again vitamin B12, homocystein and methylmalonic acid will be measured.

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Oct 21, 2014
Registry last updated: Jun 11, 2020

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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Completed