Effect of Polyvitaminics (Pyridoxine Hydrochloride, Folic Acid and Cyanocobalamin) in the Concentration of Homocysteine and Lipid Profile in Postmenopausal Women: a Randomized Controlled, Double-blind Clinical Trial

What Was Tested

The trial (phase 4) is built around Cyanocobalamin (Vitamin B12).

High levels of homocysteine (He) has been considered an important risk factor for coronary artery disease.

It had two arms (groups): Placebo Oral Tablet (placebo comparator) and Experimental group (Tenavit®) (experimental).

The registry classes the interventions as drug.

More on the Plan

Women with diabetes difficult to control or with recent myocardial infarction or thromboembolic diseases, severe hepatic impairment or activity were excluded.

In addition, patients who had any form of cancer were excluded from the group.

Study Design The women were randomly allocated to control or experimental group (30 in each group) in a double-blind controlled clinical trial.

After this period of treatment, the women were assessed.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to women only aged from 40 years up to 79 years.

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

Examples of who could join: 60 women with one year of amenorrhea, FSH greater than 30, and those with dyslipidemia.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

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

As a double-blind Cyanocobalamin (Vitamin B12) study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2008-12 with completion listed for 2010-01.

Its stated primary purpose is prevention.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cyanocobalamin (Vitamin B12) in 60 people.

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.