This trial is active, not recruiting.

Condition adenoma of large intestine
Treatments folic acid, placebo
Sponsor Brigham and Women's Hospital
Collaborator National Cancer Institute (NCI)
Start date May 1996
End date March 2004
Trial size 672 participants
Trial identifier NCT00512850, BWH-1999-P-001674/10, BWH-94-06819, CDR0000559650, R01CA067883


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Folic acid supplement 1g/day
folic acid
Intervention group 1g folic acid per day
Placebo pill once per day
One placebo pill per day

Primary Outcomes

Recurrent colorectal adenoma
time frame: May 1996-March 2004

Secondary Outcomes

recurrent adenoma by location, size, stage, number,
time frame: May1996-March 2004

Eligibility Criteria

Male or female participants up to 75 years old.

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

Additional Information

Official title The Nurses' Health Study (NHS) and Health Professionals Follow-Up Study (HPFS) Folic Acid Prevention Trial
Principal investigator Edward L. Giovannucci, MD, ScD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.