Vitamin B12 Acceptance and Biomarker Response Study

Vitamin B 12 Deficiency Clinical Trial

Official title:

Acceptance and Biomarker Response With Oral vs. Intramuscular Supplementation of Vitamin B12 in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832129
• Other study ID #: PCRG_VB12_CM
• Status: Completed
• Phase: Phase 4
• First received: April 5, 2013
• Last updated: June 12, 2016
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitamin B 12 Deficiency

Intervention

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.
• i.m. injection of vitamin B12
Intramuscular injections of 1 mg vitamin B12 will be performed at days 7, 14, and 21.

Locations

Country	Name	City	State
Switzerland	Pharmaceutical Care Research Group	Basel

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Aarelab AG, University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical response to vitamin B12 substitution	Vitamin B12 associated biomarkers (Vitamin B12, Holotranscobolamin, Homocystein, MCV, hypersegmentated neutrophils)	Day 28	No
Secondary	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.	day 28	No
Secondary	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.	day 0, day 28	No

External Links

•   Pharmaceutical Care Research Group, University of Basel
•   Study site