Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT00512850
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.
Study:
NCT00512850
Study Brief:
Protocol Section:
NCT00512850