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Vitamin B12 Acceptance and Biomarker Response Study

Primary Purpose

Vitamin B 12 Deficiency

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Oral administration of vitamin B12
i.m. injection of vitamin B12
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin B 12 Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pharmaceutical Care Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

i.m. injection of Vitamin B12

Oral administration of vitamin B12

Arm Description

Weekly i.m. injections of 1 mg Cyanocobolamin after 1, 2, and 3 weeks.

High dose (1 mg/day) oral Cyanocobolamin will be adminstrated with electronic adherence monitoring.

Outcomes

Primary Outcome Measures

Biochemical response to vitamin B12 substitution
Vitamin B12 associated biomarkers (Vitamin B12, Holotranscobolamin, Homocystein, MCV, hypersegmentated neutrophils)

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 5, 2013
Last Updated
June 12, 2016
Sponsor
University Hospital, Basel, Switzerland
Collaborators
University of Basel, Aarelab AG
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1. Study Identification

Unique Protocol Identification Number
NCT01832129
Brief Title
Vitamin B12 Acceptance and Biomarker Response Study
Official Title
Acceptance and Biomarker Response With Oral vs. Intramuscular Supplementation of Vitamin B12 in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
University of Basel, Aarelab AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin B 12 Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
i.m. injection of Vitamin B12
Arm Type
Active Comparator
Arm Description
Weekly i.m. injections of 1 mg Cyanocobolamin after 1, 2, and 3 weeks.
Arm Title
Oral administration of vitamin B12
Arm Type
Experimental
Arm Description
High dose (1 mg/day) oral Cyanocobolamin will be adminstrated with electronic adherence monitoring.
Intervention Type
Drug
Intervention Name(s)
Oral administration of vitamin B12
Other Intervention Name(s)
Cyanocobolamin, B12 "Ankermann" 1 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
i.m. injection of vitamin B12
Other Intervention Name(s)
Vitamin B12 intramuscular, Cyanocobolamin, Vitarubin Depot
Intervention Description
Intramuscular injections of 1 mg vitamin B12 will be performed at days 7, 14, and 21.
Primary Outcome Measure Information:
Title
Biochemical response to vitamin B12 substitution
Description
Vitamin B12 associated biomarkers (Vitamin B12, Holotranscobolamin, Homocystein, MCV, hypersegmentated neutrophils)
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
taking and timing adherence with oral vitamin B12
Description
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.
Time Frame
day 28
Title
Comparison of patient acceptance of oral vs. i.m. vitamin B12 supplementation
Description
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.
Time Frame
day 0, day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt E Hersberger, Professor
Organizational Affiliation
Pharmaceutical Care Research Group
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cyrill Jeger, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philipp N Walter, MSc
Organizational Affiliation
Pharmaceutical Care Research Group
Official's Role
Study Director
Facility Information:
Facility Name
Pharmaceutical Care Research Group
City
Basel
ZIP/Postal Code
CH-4056
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
28421567
Citation
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.
Results Reference
derived

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Vitamin B12 Acceptance and Biomarker Response Study

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