Vitamin Deficiencies and Suppletion in Morbid Obesity

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Vitamin Deficiencies and Suppletion in Morbid Obesity

Conditions
-----------------
Vitamin B12 Deficiency

Intervention / Treatment
-----------------
* Drug: Hydroxocobalamin
* Drug: FitForMe vitamin B12


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hydroxocobalamin injection<br>25 patients receive the standard treatment of a vitamin B12 deficiency: hydroxocobalamin injection | Drug: Hydroxocobalamin<br>* 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.<br>|
| Active Comparator: FitForMe vitamin B12 tablets<br>25 patients receive a daily dose vitamine B12 tablets | Drug: FitForMe vitamin B12<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in patients with vitamin B12 deficiency | 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. | 6 months after initiating therapy |