The Nurses' Health Study (NHS) and Health Professionals Follow-Up Study (HPFS) Folic Acid Prevention Trial

Brigham and Women's Hospital0 sites672 target enrollmentMay 1996

ConditionsAdenoma of Large Intestine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adenoma of Large Intestine
Sponsor: Brigham and Women's Hospital
Enrollment: 672
Primary Endpoint: Recurrent colorectal adenoma
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 1996

End Date

February 1, 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel