Effect of Homocysteine-lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease

What Was Tested

This registered phase 2 trial tested Cyanocobalamin (Vitamin B12).

Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (CAD) and peripheral artery disease (PAD).

B-group vitamin-supplements have variable been reported to have positive or neutral effects on endothelial function.

It had two arms (groups): R (active comparator) and V (active comparator).

Rosuvastatin treatment for 6 weeks and after that combined treatment with rosuvastatin and vitamin supplementation for additional 6 weeks.

Vitamin supplementation with folic acid, vitamin B12 and B6 for 6 weeks and after that combined treatment with vitamin supplementation and rosuvastatin.

The registry classes the interventions as drug.

More on the Plan

After 6 weeks all pts receive rosuvastatin and vitamin supplementation in combination for additional 6 weeks.

Who Took Part

The registry lists 36 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: History of percutaneous coronary intervention (PTCA or stenting).

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: myocardial infarction or acute coronary syndrome or bypass surgery \<3 month ago; ongoing treatment with statins; ongoing vitamin supplementation with folic acid and b vitamins.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

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

It started in 2005-01 with completion listed for 2007-02.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Flow mediated dilatation (FMD) (time frame: after 6 weeks of randomized treatment and after 6 weeks of combined treatment).

It also tracked 1 secondary outcome, for example changes in biochemistry parameters.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cyanocobalamin (Vitamin B12) in 36 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.