Folic Acid in Preventing Colorectal Polyps in Patients With Previous Colorectal Polyps
- Conditions
- Adenoma of Large Intestine
- Registration Number
- NCT00512850
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming. The use of folic acid may prevent colorectal cancer.
PURPOSE: This randomized clinical trial is studying how well folic acid works compared with a placebo in preventing colorectal polyps in patients who have had previous colorectal polyps.
- Detailed Description
OBJECTIVES:
Primary
* Determine if folic acid supplementation lowers the adenoma recurrence rate.
Secondary
* Determine the number of adenomas per patient and the size and histology of the adenoma.
* Assess the interaction between folic acid and alcohol, methionine, and aspirin intake.
* Assess the interaction between folic acid and pretrial and midtrial folate levels.
* Assess other complementary biomarkers such as DNA methylation and blood folate level as risk factors for polyp recurrence.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral folic acid once daily.
* Arm II: Patients receive oral placebo once daily. At least 1 year after beginning treatment, patients are sent a blood collection kit in order to measure plasma vitamin B12 levels, to measure folate to assess compliance.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 672
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Recurrent colorectal adenoma May 1996-March 2004
- Secondary Outcome Measures
Name Time Method recurrent adenoma by location, size, stage, number, May1996-March 2004