Folic Acid in Preventing Colorectal Polyps in Patients With Previous Colorectal Polyps

March 2, 2017 updated by: Edward Giovannucci, Brigham and Women's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

672

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Participated in the Nurses' Health Study (NHS I) or the Health Professionals Follow-Up Study (HPFS) and have had a previous confirmed diagnosis of adenomatous polyp of the colon or rectum
  • Plan on having an endoscopy within 4 years after initiation of the trial
  • Must release medical records regarding past and any future endoscopies

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Plasma vitamin B12 concentration of ≥ 300 pg/mL or have a vitamin B12 concentration between 200 and 299 pg/mL and a methylmalonic acid (MMA) level ≤ 32 µg/L

Exclusion criteria:

  • Diagnosis of cancer other than non-melanoma skin cancer, or early stage breast or prostate cancer
  • Diagnosis of homocystinemia
  • Diagnosis of pernicious anemia
  • Any gastrointestinal disorder that could lead to a vitamin B12 deficiency
  • Diagnosis of cirrhosis or pancreatitis
  • Diagnosis of epilepsy, Alzheimer's disease, Parkinsonism, and psychiatric disorders that may interfere with normal functioning

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

  • No prior gastrectomy, total colectomy, or pancreatectomy
  • Other concurrent multivitamins or supplements that contain folic acid (they may take specific supplements, such as A, C, E, calcium, and iron, or antioxidant formula vitamins)
  • No concurrent methotrexate or anticonvulsant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Folic acid
Folic acid supplement 1g/day
Dietary supplement: Folic acid
Intervention group 1g folic acid per day
OTHER: Placebo
Placebo pill once per day
Other: Placebo
One placebo pill per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrent colorectal adenoma
Time Frame: May 1996-March 2004
May 1996-March 2004

Secondary Outcome Measures

Outcome Measure
Time Frame
recurrent adenoma by location, size, stage, number,
Time Frame: May1996-March 2004
May1996-March 2004

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Cancer Institute (NCI)
Dana-Farber/Brigham and Women's Cancer Center

Investigators

  • Principal Investigator: Edward L. Giovannucci, MD, ScD, Dana-Farber/Brigham and Women's Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1996

Primary Completion (ACTUAL)

March 1, 2004

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

August 6, 2007

First Submitted That Met QC Criteria

August 6, 2007

First Posted (ESTIMATE)

August 8, 2007

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BWH-1999-P-001674/10
  • CDR0000559650 (REGISTRY: PDQ (Physician Data Query))
  • BWH-94-06819 (OTHER: Brigham and Women's Hospital Legacy #)
  • R01CA067883 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adenoma of Large Intestine

Clinical Trials on Folic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe