Vitamin B12 Acceptance and Biomarker Response Study

June 12, 2016 updated by: Philipp Walter, PhD, University Hospital, Basel, Switzerland

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, CH-4056
        • Pharmaceutical Care Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: i.m. injection of Vitamin B12
Weekly i.m. injections of 1 mg Cyanocobolamin after 1, 2, and 3 weeks.
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:
  • Cyanocobolamin
  • Vitamin B12 intramuscular
  • Vitarubin Depot
Experimental: Oral administration of vitamin B12
High dose (1 mg/day) oral Cyanocobolamin will be adminstrated with electronic adherence monitoring.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical response to vitamin B12 substitution
Time Frame: Day 28
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
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.
day 28
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.
day 0, day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

University of Basel
Aarelab AG

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

April 5, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (Estimate)

April 15, 2013

Study Record Updates

Last Update Posted (Estimate)

June 14, 2016

Last Update Submitted That Met QC Criteria

June 12, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCRG_VB12_CM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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