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Folate and Protection Against Cervical Cancer

This study has been terminated.
Sponsor:
Collaborator:
World Cancer Research Fund International
Information provided by:
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00220532
First received: September 13, 2005
Last updated: September 11, 2006
Last verified: September 2006

September 13, 2005
September 11, 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 ClinicalTrials.gov 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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
180
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

Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00220532
STH 13608
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