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

April 3, 2019 updated by: Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital

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

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Papanicolaou smear result (control group)
women who did not have intraepithelial neoplasia as a result of smear
Vitamin B12 and folate levels in blood
Other: Papanicolaou smear result (study group)
women who have atypical squamous cells of undetermined significance (ASCUS) as a result of smear
Vitamin B12 and folate levels in blood

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

May 30, 2015

Study Completion (Actual)

May 30, 2015

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

May 1, 2014

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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