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

Serum Levels of Folate And Vitamine B12 in Patients Infected With HPV and Diagnosed Atypical Squamous Cells of Undetermined Significance in Cervical Cytology

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03903952

Enrollment

200

Registered

2019-04-04

Start date

2014-05-01

Completion date

2015-05-30

Last updated

2019-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ASC-US, Human Papilloma Virus

Keywords

ASCUS, HPV, Vitamine B12, Folate

Brief summary

Non-classified atypical squamous cells (ASCUS) is the most common abnormal cervical cytology (%39). The risk of cervical intraepithelial neoplasia 2-3 is 5% and the risk of carcinoma is around 0.1% after diagnosis. Mostly human papillomavirus (HPV) is responsible for this transition. Most of them are transient, but some infections become persistent and can progress into precancer and invasive cancer. In the process of progression to cancer; patients with cell cycle problems are thought to be at risk. In some studies, B12 and folate deficiency, which play a role in DNA synthesis and repair, have been shown to induce incorrect binding of uracil to DNA, leading to DNA breakage and repair disorder. Therefore, in this study, it has been aimed that the relation of presence of atypical squamous cells and HPV persistence with folate and vitamin B12 levels which effect on immune system.

Detailed description

Participants were divided into two groups according to their smear results; atypical squamous cells of undetermined significance (ASCUS) (study group: 100 patients) and women who did not have intraepithelial neoplasia as a result of smear (control group: 100 patients). 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.

Interventions

DIETARY_SUPPLEMENTVitamin B12 and folate

Vitamin B12 and folate levels in blood

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* Patients taking B12 and folate supplement due to mix type anemia * patients taking active vitamin B12 and folate-containing vitamin supplements * pregnant women * women with other cervical intraepithelial lesions such as low grade squamous intraepithelial lesion (LGSIL), high grade squamous intraepithelial lesion (HGSIL) or high grade squamous intraepithelial lesion can not be excluded (ASC-H) in smear * patients with cervical cancer diagnosis * patients who were operated due to cervical cancer * patients who had HPV vaccine * patients with a diagnosis that can inhibit B12 and folate absorption in gastro-intestinal tract * vegetarians

Design outcomes

Primary

Measure	Time frame	Description
the vitamine B12 levels .	1 year	the vitamine B12 levels in patients with ASCUS (+) smear.
The folate levels	1 year	the folate levels in patients with ASCUS (+) smear.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026