Vitamin B12 Acceptance and Biomarker Response Study

Phase 4

Completed

• Conditions: Vitamin B 12 Deficiency
• Interventions: Drug: i.m. injection of vitamin B12; Drug: Oral administration of vitamin B12

• Registration Number: NCT01832129
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-05
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-15
• Study Start: 2013-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-12
• Last Update Posted: 2016-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
i.m. injection of Vitamin B12	i.m. injection of vitamin B12	Weekly i.m. injections of 1 mg Cyanocobolamin after 1, 2, and 3 weeks.
Oral administration of vitamin B12	Oral administration of vitamin B12	High dose (1 mg/day) oral Cyanocobolamin will be adminstrated with electronic adherence monitoring.

Primary Outcome Measures

Name	Time	Method
Biochemical response to vitamin B12 substitution	Day 28	Vitamin B12 associated biomarkers (Vitamin B12, Holotranscobolamin, Homocystein, MCV, hypersegmentated neutrophils)

Secondary Outcome Measures

Name	Time	Method
taking and timing adherence with oral vitamin B12	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.
Comparison of patient acceptance of oral vs. i.m. vitamin B12 supplementation	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.

Trial Locations

Locations (1)

Pharmaceutical Care Research Group; 🇨🇭 Basel, Switzerland