Vitamin B12 Acceptance and Biomarker Response Study

Phase 4 Completed 37 enrolled University Hospital, Basel, Switzerland Aarelab AG · collab University of Basel · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2013-05
Primary completion: 2015-12
Completion: 2015-12

Outcome

Missed primary endpoint

paper the primary hypothesis that oral VB12 treatment would be noninfe-rior to IM treatment was rejected. PMID 28421567 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Hydroxocobalamin	Unknown	1 mg	Intramuscular
Subject	Vitamin B12	Other / unclassified	1 mg	Oral