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

Primary Purpose

Adenoma of Large Intestine

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Folic acid

Placebo

About this trial

This is an interventional prevention trial for Adenoma of Large Intestine focused on measuring Folic acid, Adenoma of Large Intestine

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Folic acid

Placebo

Arm Description

Folic acid supplement 1g/day

Placebo pill once per day

Outcomes

Primary Outcome Measures

Recurrent colorectal adenoma

Secondary Outcome Measures

recurrent adenoma by location, size, stage, number,

Full Information

NCT ID

NCT00512850

First Posted

August 6, 2007

Last Updated

March 2, 2017

Sponsor

Brigham and Women's Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00512850

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

May 1996 (undefined)

Primary Completion Date

March 2004 (Actual)

Study Completion Date

February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenoma of Large Intestine

Keywords

Folic acid, Adenoma of Large Intestine

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

672 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Folic acid

Arm Type

Other

Arm Description

Folic acid supplement 1g/day

Arm Title

Placebo

Arm Type

Other

Arm Description

Placebo pill once per day

Intervention Type

Dietary Supplement

Intervention Name(s)

Folic acid

Intervention Description

Intervention group 1g folic acid per day

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

One placebo pill per day

Primary Outcome Measure Information:

Title

Recurrent colorectal adenoma

Time Frame

May 1996-March 2004

Secondary Outcome Measure Information:

Title

recurrent adenoma by location, size, stage, number,

Time Frame

May1996-March 2004

10. Eligibility

Sex

All

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward L. Giovannucci, MD, ScD

Organizational Affiliation

Dana-Farber/Brigham and Women's Cancer Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

19864409

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. Epub 2009 Oct 28.

Results Reference

result

PubMed Identifier

21170989

Citation

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. Epub 2011 Apr 1.

Results Reference

result

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

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