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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


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 B12

Comparison of patient acceptance of oral vs. i.m. vitamin B12 supplementation


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


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

Page last updated: August 23, 2015

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