Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2014-10-31
2016-06-30
Brief Summary
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Detailed Description
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Daily oral use of vitamin B12 tablets are may be as effective as vitamin B12 injections.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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hydroxocobalamin injection
25 patients receive the standard treatment of a vitamin B12 deficiency: hydroxocobalamin injection
Hydroxocobalamin
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 tablets
25 patients receive a daily dose vitamine B12 tablets
FitForMe 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.
Interventions
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Hydroxocobalamin
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
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.
Eligibility Criteria
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Inclusion Criteria
* Vitamin B12 deficiency 6-12 months after surgery
* All patients underwent a Roux-en-Y gastric bypass
Exclusion Criteria
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
18 Months
65 Years
MALE
No
Sponsors
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Rijnstate Hospital
OTHER
Responsible Party
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Locations
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Rijnstate hospital
Arnhem, , Netherlands
Countries
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References
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Schijns W, Homan J, van der Meer L, Janssen IM, van Laarhoven CJ, Berends FJ, Aarts EO. Efficacy of oral compared with intramuscular vitamin B-12 supplementation after Roux-en-Y gastric bypass: a randomized controlled trial. Am J Clin Nutr. 2018 Jul 1;108(1):6-12. doi: 10.1093/ajcn/nqy072.
Other Identifiers
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VITAALII
Identifier Type: -
Identifier Source: org_study_id
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