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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00220532

Enrollment

180

Registered

2005-09-22

Start date

2005-07-31

Completion date

2007-05-31

Last updated

2006-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

Randomised placebo controlled intervention trial, Folic acid, Riboflavin, cervical cancer

Brief 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.

Detailed 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.

Interventions

DRUGFolic acid with riboflavin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

0 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of regression of CIN1 to normal over a 12 month intervention	—

Secondary

Measure	Time frame
DNA strand breakage, in cervical cells	—
DNA hypomethylation, in cervical cells	—
Cervical cell folic acid	—
HPV persistence over 12 months of intervention	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026