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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vitamin B 12 Deficiency Drug: Oral administration of vitamin B12 Drug: i.m. injection of vitamin B12 Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acceptance and Biomarker Response With Oral vs. Intramuscular Supplementation of Vitamin B12 in Primary Care
Study Start Date : May 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins

Arms and Interventions
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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:
  • Vitamin B12 intramuscular
  • Cyanocobolamin
  • 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


Outcome Measures
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Primary Outcome Measures :
  1. Biochemical response to vitamin B12 substitution [ Time Frame: Day 28 ]
    Vitamin B12 associated biomarkers (Vitamin B12, Holotranscobolamin, Homocystein, MCV, hypersegmentated neutrophils)


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832129


Locations
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Switzerland
Pharmaceutical Care Research Group
Basel, Switzerland, CH-4056
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University of Basel
Aarelab AG
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Philipp Walter, PhD, MSc, University of Basel
ClinicalTrials.gov Identifier: NCT01832129    
Other Study ID Numbers: PCRG_VB12_CM
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Vitamin B 12 Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
 Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Micronutrients
Physiological Effects of Drugs
Hematinics