Vitamin B12 Acceptance and Biomarker Response Study

Study Overview
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Brief Summary
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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.

Official Title
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Acceptance and Biomarker Response With Oral vs. Intramuscular Supplementation of Vitamin B12 in Primary Care

Conditions
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Vitamin B 12 Deficiency

Intervention / Treatment
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* Drug: Oral administration of vitamin B12
* Drug: i.m. injection of vitamin B12


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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: i.m. injection of Vitamin B12<br>Weekly i.m. injections of 1 mg Cyanocobolamin after 1, 2, and 3 weeks. | Drug: i.m. injection of vitamin B12<br>* Intramuscular injections of 1 mg vitamin B12 will be performed at days 7, 14, and 21.<br>* Other names: Vitarubin Depot;|
| Experimental: Oral administration of vitamin B12<br>High dose (1 mg/day) oral Cyanocobolamin will be adminstrated with electronic adherence monitoring. | Drug: Oral administration of vitamin B12<br>* 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.<br>* Other names: B12 Ankermann 1 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical response to vitamin B12 substitution | Vitamin B12 associated biomarkers (Vitamin B12, Holotranscobolamin, Homocystein, MCV, hypersegmentated neutrophils) | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| taking and timing adherence with oral vitamin B12 | 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. | day 28 | 
| Comparison of patient acceptance of oral vs. i.m. vitamin B12 supplementation | 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. | day 0, day 28 |