Can B12 and Folate Levels Predict HPV Penetration in Patients With ASCUS?

What Was Tested

This registered not phased trial tested Cyanocobalamin (Vitamin B12).

Non-classified atypical squamous cells (ASCUS) is the most common abnormal cervical cytology (%39).

Mostly human papillomavirus (HPV) is responsible for this transition.

It had two arms (groups): Papanicolaou smear result (control group) (other) and Papanicolaou smear result (study group) (other).

Women who did not have intraepithelial neoplasia as a result of smear.

The registry classes the interventions as dietary supplement.

More on the Plan

Patients who had well preserved sufficient number of squamous epithelial cells, who did not have bleeding, fixation failure, inflammation or atrophy, and had negative cervical cytology smear were considered as control group.

HPV test was also requested from the study group.

B12 and folate blood levels were compared between the groups.

Who Took Part

The registry lists 200 actual participants took part.

It was open to women only aged from 30 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Female patients aged between 30-65 who were undergoing smear tests with the aim of control. Body mass index (BMI) lower than 35. Participants did not have any chronic diseases.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: patients taking b12 and folate supplement due to mix type anemia; patients taking active vitamin b12 and folate-containing vitamin supplements; pregnant women.

How the Study Was Run

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

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

Being open-label, the Cyanocobalamin (Vitamin B12) study did not mask who received what.

It started in 2014-05-01 with completion listed for 2015-05-30.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: the vitamine B12 levels (time frame: 1 year). The folate levels (time frame: 1 year).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Cyanocobalamin (Vitamin B12) in 200 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.