A Randomised Placebo-Controlled Trial to Evaluate Interactions Between Riboflavin and Folate Intake and Genotype in Reducing Risk of Cervical Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Rate of regression of CIN1 to normal over a 12 month intervention
研究概览
简要总结
This is a randomised double-blind placebo-controlled trial to see whether giving a low dose of the vitamins folic acid and riboflavin is beneficial to women who have very low grade abnormalities of the cervical cells.
详细描述
The overall aim of the study is to evaluate interactions between intakes of folic acid and riboflavin with a common polymorphism relevant to folate metabolism, in determining the risk of cervical cancer in women who carry high risk human papillomavirus.
We will test the following hypotheses:
Supplements of riboflavin and folic acid will increase the rate of regression of low grade cervical intra epithelial neoplasia (CIN1).
Effects of supplemental folic acid and riboflavin on CIN1 regression are modulated by a common polymorphism in the MTHFRC677T gene.
We will recruit women with biopsy-proven CIN1 and carrying high risk HPV infection, and randomise to a 12month intervention of 1.2mg folic acid and 5mg riboflavin or placebo. The primary outcome will be regression of biopsy-proven CIN1, and secondary outcomes will include measures of DNA stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •biopsy-diagnosed CIN1 infection with oncogenic HPV
排除标准
- •Any other stage of cervical abnormality pregnant or planning a pregnancy diabetic taking B vitamin supplements taking anti-epileptic treatment taking methotrexate bleeding after intercourse abnormal GI function infection with chlamydia, HIV or other agent
结局指标
主要结局
Rate of regression of CIN1 to normal over a 12 month intervention
次要结局
- DNA strand breakage, in cervical cells
- DNA hypomethylation, in cervical cells
- Cervical cell folic acid
- HPV persistence over 12 months of intervention