Know Cancer

or
forgot password

A Randomised Placebo-Controlled Trial to Evaluate Interactions Between Riboflavin and Folate Intake and Genotype in Reducing Risk of Cervical Cancer


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

A Randomised Placebo-Controlled Trial to Evaluate Interactions Between Riboflavin and Folate Intake and Genotype in Reducing Risk of Cervical Cancer


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of regression of CIN1 to normal over a 12 month intervention

Principal Investigator

Hilary J Powers, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Human Nutrition Unit, University of Sheffield

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

STH 13608

NCT ID:

NCT00220532

Start Date:

July 2005

Completion Date:

May 2007

Related Keywords:

  • Cervical Cancer
  • Randomised placebo controlled intervention trial
  • Folic acid
  • Riboflavin
  • cervical cancer
  • Uterine Cervical Neoplasms

Name

Location