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

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ClinicalTrials.gov Identifier: NCT03903952
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
Sisli Hamidiye Etfal Training and Research Hospital
Information provided by (Responsible Party):
Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital

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.

Condition or disease Intervention/treatment Phase
ASC-US Human Papilloma Virus Dietary Supplement: Vitamin B12 and folate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : May 1, 2014
Actual Primary Completion Date : May 30, 2015
Actual Study Completion Date : May 30, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Papanicolaou smear result (control group)
women who did not have intraepithelial neoplasia as a result of smear
Dietary Supplement: Vitamin B12 and folate
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
Dietary Supplement: Vitamin B12 and folate
Vitamin B12 and folate levels in blood




Primary Outcome Measures :
  1. the vitamine B12 levels . [ Time Frame: 1 year ]
    the vitamine B12 levels in patients with ASCUS (+) smear.

  2. The folate levels [ Time Frame: 1 year ]
    the folate levels in patients with ASCUS (+) smear.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
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Responsible Party: Nefise Nazlı YENIGUL, Ph.D. Assistant Professor Department of Obstetrics and Gynecology, Sanliurfa Mehmet Akif Inan Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03903952    
Other Study ID Numbers: 714
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: May 2014

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital:
ASCUS
HPV
Vitamine B12
Folate
Additional relevant MeSH terms:
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Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Vitamin B 12
Hydroxocobalamin
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Vitamin B Complex
Hematinics