Vitamin B 12 Deficiency
Conditions
Brief summary
In this study, biomarker response after supplementation with oral and intramuscular vitamin B12 will be compared in a randomized clinical trial. Electronic compliance monitoring will be used to control for non compliance as a possible confounder in oral treatment. Additionally subjective acceptance in terms of presumed preferences will be compared with oral vs. intramuscular supplementation of vitamin B12 in the view of the patient.
Interventions
DRUGOral administration of vitamin B12
Daily high dose oral vitamin B12 (1mg) will be administered over 4 weeks. The patients adherence to this regimen will be monitored with an electronic punch card.
DRUGi.m. injection of vitamin B12
Intramuscular injections of 1 mg vitamin B12 will be performed at days 7, 14, and 21.
Sponsors
University of Basel
Aarelab AG
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* General practitioner's prescription for Vitamin B12 deficiency testing * Age\> 18 years * Ability to give written informed consent * Vitamin B12 serum concentrations \< 200pmol/l * indication for vitamin B12 supplementation according to the General practitioners estimation
Exclusion criteria
* Patients with incorrect intake of vitamin preparations containing vitamin B12 * Patients with previously diagnosed dementia * Patients with known hereditary transcobalamin transportation defects * lack of written and/or oral understanding in German, French, Italian or English languages
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical response to vitamin B12 substitution | Day 28 | Vitamin B12 associated biomarkers (Vitamin B12, Holotranscobolamin, Homocystein, MCV, hypersegmentated neutrophils) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| taking and timing adherence with oral vitamin B12 | day 28 | Adherence to oral vitamin B12 supplementation will be measured with an electronic adherence monitoring device. The number of doses taken (taking adherence) and the number of doses taken within the defined time-frame (timing adherence) will be measured. |
| Comparison of patient acceptance of oral vs. i.m. vitamin B12 supplementation | day 0, day 28 | Acceptance of the two routes of administration of vitamin B12 substitution by the patients will be measured by specific questionnaires before and after exposure to the medication in both arms. |
Countries
Switzerland
Outcome results
None listed