Cervical Cancer Clinical Trial
Official title:
A Randomised Placebo-Controlled Trial to Evaluate Interactions Between Riboflavin and Folate Intake and Genotype in Reducing Risk of Cervical Cancer
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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