Polyp Prevention Trial
- Determine if folic acid supplementation lowers the adenoma recurrence rate.
- 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.
Allocation: Randomized, Primary Purpose: Prevention
Diagnosis of a recurrent adenomatous polyp(s) of the colorectum on subsequent colonoscopy
Edward L. Giovannucci, MD, ScD
Dana-Farber/Brigham and Women's Cancer Center
United States: Federal Government