Vitamin B12 Deficiency
Conditions
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.
Interventions
DRUGHydroxocobalamin
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.
DRUGFitForMe vitamin B12
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.
Sponsors
Rijnstate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Months to 65 Years
Healthy volunteers
No
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
1. Creatin \>150micromol/L 2. Liver enzymes \>2 times upper limit 3. Other bariatric operations 4. Intercurrent diseases 5. Gastro-intestinal diseases 6. Psychiatric disease 7. Medicines which influences bone density 8. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction in patients with vitamin B12 deficiency | 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. |
Countries
Netherlands
Outcome results
None listed