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

Adenoma of Large Intestine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512850
• Other study ID #: BWH-1999-P-001674/10
• Secondary ID: CDR0000559650BWH
• Status: Completed
• Phase: N/A
• First received: August 6, 2007
• Last updated: March 2, 2017
• Start date: May 1996
• Est. completion date: February 1, 2017

Study information

• Verified date: March 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 672
• Est. completion date: February 1, 2017
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma of Large Intestine

Intervention

Dietary Supplement:
• Folic acid
Intervention group 1g folic acid per day

Other:
• Placebo
One placebo pill per day

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Dana-Farber/Brigham and Women's Cancer Center, National Cancer Institute (NCI)

References & Publications (2)

Figueiredo JC, Mott LA, Giovannucci E, Wu K, Cole B, Grainge MJ, Logan RF, Baron JA. Folic acid and prevention of colorectal adenomas: a combined analysis of randomized clinical trials. Int J Cancer. 2011 Jul 1;129(1):192-203. doi: 10.1002/ijc.25872. — View Citation

Wu K, Platz EA, Willett WC, Fuchs CS, Selhub J, Rosner BA, Hunter DJ, Giovannucci E. A randomized trial on folic acid supplementation and risk of recurrent colorectal adenoma. Am J Clin Nutr. 2009 Dec;90(6):1623-31. doi: 10.3945/ajcn.2009.28319. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent colorectal adenoma		May 1996-March 2004
Secondary	recurrent adenoma by location, size, stage, number,		May1996-March 2004