Folate and Protection Against Cervical Cancer
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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 |
- Rate of regression of CIN1 to normal over a 12 month intervention
- 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 |
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 |
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| United Kingdom | |
| University of Sheffield | |
| Sheffield, South Yorkshire, United Kingdom, S10 2TN | |
| 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 |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses Photosensitizing Agents Radiation-Sensitizing Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on June 18, 2013