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

NCT ID: NCT03903952

Last Updated: 2019-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-01
• Study Completion Date: 2015-05-30

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.

Conditions

ASC-US; Human Papilloma Virus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Papanicolaou smear result (control group)

women who did not have intraepithelial neoplasia as a result of smear

Group Type: OTHER

Vitamin B12 and folate

Intervention Type: DIETARY_SUPPLEMENT

Vitamin B12 and folate levels in blood

Papanicolaou smear result (study group)

women who have atypical squamous cells of undetermined significance (ASCUS) as a result of smear

Group Type: OTHER

Vitamin B12 and folate

Intervention Type: DIETARY_SUPPLEMENT

Vitamin B12 and folate levels in blood

Interventions

Vitamin B12 and folate

Vitamin B12 and folate levels in blood

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role: collaborator

Sanliurfa Mehmet Akif Inan Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nefise Nazlı YENIGUL

Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

714

Identifier Type: -

Identifier Source: org_study_id