WENBIT - Western Norway B Vitamin Intervention Trial

What Was Tested

This registered phase 3 trial tested Cyanocobalamin (Vitamin B12).

It had four arms (groups): 1 (active comparator), 2 (active comparator), 3 (active comparator) and 4 (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

In the United States and United Kingdom many food products are fortified with folic acid.

The Food and Drug administration in the United States has made fortification with folic acid mandatory for some products from 1998.

Data that are already recorded according to routine procedures at the participating centers, are owned by the center or department delivering the data and by WENBIT.

The WENBIT Steering Committee has the disposal of all data registered in the WENBIT database, and any use of these data including the preparation and publication of scientific reports must be approved by The Steering Committee.

Who Took Part

3096 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: Adults ≥ 18 years able to give informed consent.

The full record lists 3 inclusion and 5 exclusion criteria.

How the Study Was Run

The set-up was randomized, factorial and quadruple-blind.

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

Blinding on both sides kept the participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 1999-04 with completion listed for 2007-06.

It ran at 2 sites in Norway (2).

Its stated primary purpose is prevention.

What Was Measured

It also tracked 6 secondary outcomes, for example Stable angina with angiographic verified progression, Myocardial revascularization, Fatal and non-fatal thromboembolic stroke and Cancer.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cyanocobalamin (Vitamin B12) in 3096 people.

With 3096 participants it is a large trial for this field.

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.