Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12)

What Was Tested

The paper reports a study of Cyanocobalamin (Vitamin B12), published as a randomized controlled trial.

This trial has been registered with ClinicalTrials.gov, number NCT 01476007, and under EUDRACT number 2010-024129-20.

Who Took Part

The study group was 3556 patients.

By PubMed's age tags, the people studied were older adults, both men and women.

The minimum number of patients required for the study was calculated as 320 (160 in each arm).

Eligible patients will be randomly assigned to one of the two treatment arms.

How the Study Was Run

The researchers set it up as a randomized, multicenter and parallel-group study.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

More than one site took part, so the patients came from several places.

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

The main outcome variable to be monitored in both treatment arms is the normalisation of the serum vitamin B12 concentration at weeks 8, 26 and 52; the secondary outcome variables include the serum concentration of vitamin B12 (in pg/ml), adherence to treatment, quality of life (EuroQoL-5D questionnaire), patient 3satisfaction and patient preferences.

All statistical tests will be performed with intention to treat and per protocol.

Logistic regression with random effects will be used to adjust for prognostic factors.

Confounding factors or factors that might alter the effect recorded will be taken into account in analyses.

What Was Measured

Topics PubMed links to this paper include Comparative Effectiveness Research, Drug Administration Routes, Patient Compliance, Patient Satisfaction, Primary Health Care, Quality of Life and Sample Size.

What This Means in Plain Language

The paper is a randomized, multicenter and parallel-group study of Cyanocobalamin (Vitamin B12) in 3556 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

The abstract goes on to report its results in about 3 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2012 (BMC public health), a journal based in England.

More context: the Cyanocobalamin (Vitamin B12) compound page.