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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Dana-Farber/Brigham and Women's Cancer Center
Information provided by (Responsible Party):
Edward Giovannucci, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00512850
First received: August 6, 2007
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Adenoma of Large Intestine
Dietary Supplement: Folic acid
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Nurses' Health Study (NHS) and Health Professionals Follow-Up Study (HPFS) Folic Acid Prevention Trial

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Recurrent colorectal adenoma [ Time Frame: May 1996-March 2004 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • recurrent adenoma by location, size, stage, number, [ Time Frame: May1996-March 2004 ] [ Designated as safety issue: No ]

Enrollment: 672
Study Start Date: May 1996
Estimated Study Completion Date: January 2016
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Folic acid
Folic acid supplement 1g/day
Dietary Supplement: Folic acid
Intervention group 1g folic acid per day
Placebo
Placebo pill once per day
Other: Placebo
One placebo pill per day

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.
  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512850

Sponsors and Collaborators
Brigham and Women's Hospital
Dana-Farber/Brigham and Women's Cancer Center
Investigators
Principal Investigator: Edward L. Giovannucci, MD, ScD Dana-Farber/Brigham and Women's Cancer Center
  More Information

Publications:
Responsible Party: Edward Giovannucci, Edward Giovannucci, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00512850     History of Changes
Other Study ID Numbers: BWH-1999-P-001674/10, CDR0000559650, BWH-94-06819, R01CA067883
Study First Received: August 6, 2007
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Folic acid
Adenoma of Large Intestine

Additional relevant MeSH terms:
Adenoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Folic Acid
Vitamin B Complex
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on November 20, 2014