Serum Levels of Folate And Vitamine B12 in Patients Infected With HPV and Diagnosed Atypical Squamous Cells of Undetermined Significance in Cervical Cytology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- The folate levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Papanicolaou smear result (control group)
women who did not have intraepithelial neoplasia as a result of smear
干预措施: Vitamin B12 and folate (Dietary Supplement)
Papanicolaou smear result (study group)
women who have atypical squamous cells of undetermined significance (ASCUS) as a result of smear
干预措施: Vitamin B12 and folate (Dietary Supplement)
结局指标
主要结局
The folate levels
时间窗: 1 year
the folate levels in patients with ASCUS (+) smear.
the vitamine B12 levels .
时间窗: 1 year
the vitamine B12 levels in patients with ASCUS (+) smear.
次要结局
未报告次要终点
研究者
Nefise Nazlı YENIGUL
Ph.D. Assistant Professor Department of Obstetrics and Gynecology
Sanliurfa Mehmet Akif Inan Education and Research Hospital