Vitamin B12 Acceptance and Biomarker Response Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Basel, Switzerland
Sponsor:
Collaborators:
University of Basel
Aarelab, Clinical Laboratory, Olten, Switzerland
Information provided by (Responsible Party):
Philipp Walter, PhD, University of Basel
ClinicalTrials.gov Identifier:
NCT01832129
First received: April 5, 2013
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Vitamin B 12 Deficiency
Drug: Oral administration of vitamin B12
Drug: i.m. injection of vitamin B12
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acceptance and Biomarker Response With Oral vs. Intramuscular Supplementation of Vitamin B12 in Primary Care

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Biochemical response to vitamin B12 substitution [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Vitamin B12 associated biomarkers (Vitamin B12, Holotranscobolamin, Homocystein, MCV, hypersegmentated neutrophils)


Secondary Outcome Measures:
  • taking and timing adherence with oral vitamin B12 [ Time Frame: day 28 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin B12 i.m.
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: Vitamin B12 oral
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832129

Contacts
Contact: Corina Metaxas corina.metaxas@unibas.ch
Contact: Philipp Walter philipp.walter@unibas.ch

Locations
Switzerland
Pharmaceutical Care Research Group Recruiting
Basel, Switzerland, CH-4056
Contact: Corina Metaxas    +41 79 548 47 28    corina.metaxas@unibas.ch   
Contact: Philipp Walter       philipp.walter@unibas.ch   
Principal Investigator: Cyrill Jeger, MD         
Sub-Investigator: Philipp Walter, Msc         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University of Basel
Aarelab, Clinical Laboratory, Olten, Switzerland
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
  More Information

Additional Information:
No publications provided

Responsible Party: Philipp Walter, PhD, Msc, University of Basel
ClinicalTrials.gov Identifier: NCT01832129     History of Changes
Other Study ID Numbers: PCRG_VB12_CM
Study First Received: April 5, 2013
Last Updated: April 9, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Vitamin B 12
Vitamin B Complex
Vitamin B 12 Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hydroxocobalamin
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014