Folate and Protection Against Cervical Cancer

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00220532
• Other study ID #: STH 13608
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: September 11, 2006
• Start date: July 2005
• Est. completion date: May 2007

Study information

• Verified date: September 2006
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 180
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Folic acid with riboflavin

Locations

Country	Name	City	State
United Kingdom	University of Sheffield	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	World Cancer Research Fund International

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of regression of CIN1 to normal over a 12 month intervention
Secondary	DNA strand breakage, in cervical cells
Secondary	DNA hypomethylation, in cervical cells
Secondary	Cervical cell folic acid
Secondary	HPV persistence over 12 months of intervention