Folate and Protection Against Cervical Cancer
|ClinicalTrials.gov Identifier: NCT00220532|
Recruitment Status : Terminated
First Posted : September 22, 2005
Last Update Posted : September 13, 2006
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: Folic acid with riboflavin||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomised Placebo-Controlled Trial to Evaluate Interactions Between Riboflavin and Folate Intake and Genotype in Reducing Risk of Cervical Cancer|
|Study Start Date :||July 2005|
|Estimated Study Completion Date :||May 2007|
- Rate of regression of CIN1 to normal over a 12 month intervention
- DNA strand breakage, in cervical cells
- DNA hypomethylation, in cervical cells
- Cervical cell folic acid
- HPV persistence over 12 months of intervention
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220532
|University of Sheffield|
|Sheffield, South Yorkshire, United Kingdom, S10 2TN|
|Principal Investigator:||Hilary J Powers, PhD||Human Nutrition Unit, University of Sheffield|