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
  Purpose

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 Intervention Phase
Cervical Cancer
Drug: Folic acid with riboflavin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

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

Secondary Outcome Measures:
  • DNA strand breakage, in cervical cells
  • DNA hypomethylation, in cervical cells
  • Cervical cell folic acid
  • HPV persistence over 12 months of intervention

Estimated Enrollment: 180
Study Start Date: July 2005
Estimated Study Completion Date: May 2007
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220532

Locations
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
Investigators
Principal Investigator: Hilary J Powers, PhD Human Nutrition Unit, University of Sheffield
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00220532     History of Changes
Other Study ID Numbers: STH 13608
Study First Received: September 13, 2005
Last Updated: September 11, 2006
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Folic Acid
Vitamin B Complex
Riboflavin
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 22, 2014