Folate and Protection Against Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00220532
Recruitment Status : Terminated
First Posted : September 22, 2005
Last Update Posted : September 13, 2006
World Cancer Research Fund International
Information provided by:
Sheffield Teaching Hospitals NHS Foundation Trust

September 13, 2005
September 22, 2005
September 13, 2006
July 2005
Not Provided
Rate of regression of CIN1 to normal over a 12 month intervention
Same as current
Complete list of historical versions of study NCT00220532 on Archive Site
  • DNA strand breakage, in cervical cells
  • DNA hypomethylation, in cervical cells
  • Cervical cell folic acid
  • HPV persistence over 12 months of intervention
Same as current
Not Provided
Not Provided
Folate and Protection Against Cervical Cancer
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.

Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Cervical Cancer
Drug: Folic acid with riboflavin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2007
Not Provided

Inclusion Criteria:

  • biopsy-diagnosed CIN1 infection with oncogenic HPV

Exclusion Criteria:

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

Sexes Eligible for Study: Female
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
United Kingdom
STH 13608
Not Provided
Not Provided
Not Provided
Not Provided
Sheffield Teaching Hospitals NHS Foundation Trust
World Cancer Research Fund International
Principal Investigator: Hilary J Powers, PhD Human Nutrition Unit, University of Sheffield
Sheffield Teaching Hospitals NHS Foundation Trust
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP