Trial | NCT03903952  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    200
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.
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 Started
May 01
2014
Primary Completion
May 30
2015
Study Completion
May 30
2015
Last Update
Apr 05
2019

Dietary Supplement Vitamin B12 and folate [folic acid, cobalamin]

Vitamin B12 and folate levels in blood

Papanicolaou smear result (control group) Other

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

Papanicolaou smear result (study group) Other

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

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
No Results Posted