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

NCT03903952 | Completed

• 1 other identifier: 714
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ASC-US; Human Papilloma Virus

Keywords

ASCUS; HPV; Vitamine B12; Folate

Outcome Measures

Primary Outcomes (2)

• the vitamine B12 levels .

  the vitamine B12 levels in patients with ASCUS (+) smear.

  1 year

• The folate levels

  the folate levels in patients with ASCUS (+) smear.

  1 year

Study Arms (2)

Papanicolaou smear result (control group)

OTHER

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

Dietary Supplement: Vitamin B12 and folate

Papanicolaou smear result (study group)

OTHER

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

Dietary Supplement: Vitamin B12 and folate

Interventions

Vitamin B12 and folate DIETARY_SUPPLEMENT

Vitamin B12 and folate levels in blood

Papanicolaou smear result (control group); Papanicolaou smear result (study group)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanliurfa Mehmet Akif Inan Education and Research Hospital: lead
• Sisli Hamidiye Etfal Training and Research Hospital: collaborator

MeSH Terms

Conditions

Atypical Squamous Cells of the Cervix

Interventions

Vitamin B 12; Folic Acid

Condition Hierarchy (Ancestors)

Uterine Cervical Dysplasia; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 4, 2019
• Study Start: May 1, 2014
• Primary Completion: May 30, 2015
• Study Completion: May 30, 2015
• Last Updated: April 5, 2019

Record last verified: 2014-05