Vitamin B12 Acceptance and Biomarker Response Study
Information source: University Hospital, Basel, Switzerland
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitamin B 12 Deficiency
Intervention: Oral administration of vitamin B12 (Drug); i.m. injection of vitamin B12 (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital, Basel, Switzerland Official(s) and/or principal investigator(s): Kurt E Hersberger, Professor, Study Chair, Affiliation: Pharmaceutical Care Research Group Cyrill Jeger, MD, Principal Investigator Philipp N Walter, MSc, Study Director, Affiliation: Pharmaceutical Care Research Group
Overall contact: Corina Metaxas, Email: corina.metaxas@unibas.ch
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.
Clinical Details
Official title: Acceptance and Biomarker Response With Oral vs. Intramuscular Supplementation of Vitamin B12 in Primary Care
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Biochemical response to vitamin B12 substitution
Secondary outcome: taking and timing adherence with oral vitamin B12Comparison of patient acceptance of oral vs. i.m. vitamin B12 supplementation
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Corina Metaxas, Email: corina.metaxas@unibas.ch
Pharmaceutical Care Research Group, Basel CH-4056, Switzerland; Recruiting Corina Metaxas, Phone: +41 79 548 47 28, Email: corina.metaxas@unibas.ch Philipp Walter, Email: philipp.walter@unibas.ch Cyrill Jeger, MD, Principal Investigator Philipp Walter, Msc, Sub-Investigator
Additional Information
Pharmaceutical Care Research Group, University of Basel Study site
Starting date: May 2013
Last updated: August 12, 2015
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