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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

672 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-05-31

Study Completion Date

2017-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Adenoma of Large Intestine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Folic acid

Folic acid supplement 1g/day

Group Type OTHER

Folic acid

Intervention Type DIETARY_SUPPLEMENT

Intervention group 1g folic acid per day

Placebo

Placebo pill once per day

Group Type OTHER

Placebo

Intervention Type OTHER

One placebo pill per day

Interventions

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Folic acid

Intervention group 1g folic acid per day

Intervention Type DIETARY_SUPPLEMENT

Placebo

One placebo pill per day

Intervention Type OTHER

Eligibility Criteria

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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:

* 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:

* 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

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No