Can B12 and Folate Levels Predict HPV Penetration in Pati... | NCT03903952

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

NCT03903952

Sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Status

Completed

Last Update Posted

Apr 5, 2019Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

ASC-US
Human Papilloma Virus

Interventions

Vitamin B12 and folate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2014Actual

Primary Completion Date

May 30, 2015Actual

Completion Date

May 30, 2015Actual

First Submitted Date

Apr 1, 2019

First Submission Date that Met QC Criteria

Apr 3, 2019

First Posted Date

Apr 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2019

Last Update Posted Date

Apr 5, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nefise Nazlı YENIGUL, Ph.D. Assistant Professor Department of Obstetrics and Gynecology, Sanliurfa Mehmet Akif Inan Education and Research HospitalPrincipal Investigator

Lead Sponsor

Sanliurfa Mehmet Akif Inan Education and Research HospitalOTHER

Collaborators

Name	Class
Sisli Hamidiye Etfal Training and Research Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Vitamin B12 and folate	Dietary Supplement	Vitamin B12 and folate levels in blood	Papanicolaou smear result (control group) Papanicolaou smear result (study group)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065309	Atypical Squamous Cells of the Cervix

Ancestor Terms

ID	Term
D002578	Uterine Cervical Dysplasia
D011230	Precancerous Conditions
D009369	Neoplasms
D002577	Uterine Cervical Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014805	Vitamin B 12
D005492	Folic Acid

Ancestor Terms

ID	Term
D045728	Corrinoids
D045725	Tetrapyrroles
D011758	Pyrroles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided