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Folate and Protection Against Cervical Cancer

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ClinicalTrials.gov 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

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: Folic acid with riboflavin Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomised Placebo-Controlled Trial to Evaluate Interactions Between Riboflavin and Folate Intake and Genotype in Reducing Risk of Cervical Cancer
Study Start Date : July 2005
Estimated Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Rate of regression of CIN1 to normal over a 12 month intervention

Secondary Outcome Measures :
  1. DNA strand breakage, in cervical cells
  2. DNA hypomethylation, in cervical cells
  3. Cervical cell folic acid
  4. HPV persistence over 12 months of intervention

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220532

United Kingdom
University of Sheffield
Sheffield, South Yorkshire, United Kingdom, S10 2TN
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
World Cancer Research Fund International
Principal Investigator: Hilary J Powers, PhD Human Nutrition Unit, University of Sheffield

ClinicalTrials.gov Identifier: NCT00220532     History of Changes
Other Study ID Numbers: STH 13608
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 13, 2006
Last Verified: September 2006

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Randomised placebo controlled intervention trial
Folic acid
cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents