ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin B12 Acceptance and Biomarker Response Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01832129
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : June 14, 2016
Sponsor:
Collaborators:
University of Basel
Aarelab AG
Information provided by (Responsible Party):
Philipp Walter, PhD, University of Basel

April 5, 2013
April 15, 2013
June 14, 2016
May 2013
December 2015   (Final data collection date for primary outcome measure)
Biochemical response to vitamin B12 substitution [ Time Frame: Day 28 ]
Vitamin B12 associated biomarkers (Vitamin B12, Holotranscobolamin, Homocystein, MCV, hypersegmentated neutrophils)
Same as current
Complete list of historical versions of study NCT01832129 on ClinicalTrials.gov Archive Site
  • taking and timing adherence with oral vitamin B12 [ Time Frame: 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 [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
Vitamin B12 Acceptance and Biomarker Response Study
Acceptance and Biomarker Response With Oral vs. Intramuscular Supplementation of Vitamin B12 in Primary Care
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Vitamin B 12 Deficiency
  • Drug: Oral 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.
    Other Names:
    • Cyanocobolamin
    • B12 "Ankermann" 1 mg
  • Drug: i.m. injection of vitamin B12
    Intramuscular injections of 1 mg vitamin B12 will be performed at days 7, 14, and 21.
    Other Names:
    • Vitamin B12 intramuscular
    • Cyanocobolamin
    • Vitarubin Depot
  • Active Comparator: i.m. injection of Vitamin B12
    Weekly i.m. injections of 1 mg Cyanocobolamin after 1, 2, and 3 weeks.
    Intervention: Drug: i.m. injection of vitamin B12
  • Experimental: Oral administration of vitamin B12
    High dose (1 mg/day) oral Cyanocobolamin will be adminstrated with electronic adherence monitoring.
    Intervention: Drug: Oral administration of vitamin B12
Metaxas C, Mathis D, Jeger C, Hersberger KE, Arnet I, Walter P. Early biomarker response and patient preferences to oral and intramuscular vitamin B12 substitution in primary care: a randomised parallel-group trial. Swiss Med Wkly. 2017 Apr 7;147:w14421. doi: 10.4414/smw.2017.14421. eCollection 2017.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
60
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01832129
PCRG_VB12_CM
Yes
Not Provided
Not Provided
Philipp Walter, PhD, University of Basel
University Hospital, Basel, Switzerland
  • University of Basel
  • Aarelab AG
Study Chair: Kurt E Hersberger, Professor Pharmaceutical Care Research Group
Principal Investigator: Cyrill Jeger, MD
Study Director: Philipp N Walter, MSc Pharmaceutical Care Research Group
University Hospital, Basel, Switzerland
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP