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

Human Papilloma Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03903952
• Other study ID #: 714
• Status: Completed
• Phase: N/A
• Start date: May 1, 2014
• Est. completion date: May 30, 2015

Study information

• Verified date: May 2014
• Source: Sanliurfa Mehmet Akif Inan Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 30, 2015
• Est. primary completion date: May 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• ASC-US
• Human Papilloma Virus
• Papilloma

Intervention

Dietary Supplement:
• Vitamin B12 and folate
Vitamin B12 and folate levels in blood

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sanliurfa Mehmet Akif Inan Education and Research Hospital	Sisli Hamidiye Etfal Training and Research Hospital

Outcome

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