Vitamin B12 Acceptance and Biomarker Response Study

What Was Tested

This registered phase 4 trial tested Cyanocobalamin (Vitamin B12).

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.

It had two arms (groups): i.m. injection of Vitamin B12 (active comparator) and Oral administration of vitamin B12 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 37 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: General practitioner's prescription for Vitamin B12 deficiency testing. Age\> 18 years. Ability to give written informed consent. Indication for vitamin B12 supplementation according to the General practitioners estimation.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: patients with incorrect intake of vitamin preparations containing vitamin b12; patients with previously diagnosed dementia; patients with known hereditary transcobalamin transportation defects.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Cyanocobalamin (Vitamin B12) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2013-05 with completion listed for 2015-12.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Biochemical response to vitamin B12 substitution (time frame: Day 28).

It also tracked 2 secondary outcomes, for example taking and timing adherence with oral vitamin B12 and Comparison of patient acceptance of oral vs. i.m. vitamin B12 supplementation.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cyanocobalamin (Vitamin B12) in 37 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.