Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-02-21 @ 9:19 PM
Study NCT ID:
NCT00512850
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2007-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Folic Acid in Preventing Colorectal Polyps in Patients With Previous Colorectal Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 672}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-02', 'studyFirstSubmitDate': '2007-08-06', 'studyFirstSubmitQcDate': '2007-08-06', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent colorectal adenoma', 'timeFrame': 'May 1996-March 2004'}], 'secondaryOutcomes': [{'measure': 'recurrent adenoma by location, size, stage, number,', 'timeFrame': 'May1996-March 2004'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Folic acid', 'Adenoma of Large Intestine'], 'conditions': ['Adenoma of Large Intestine']}, 'referencesModule': {'references': [{'pmid': '19864409', 'type': 'RESULT', '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.'}, {'pmid': '21170989', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming. The use of folic acid may prevent colorectal cancer.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine if folic acid supplementation lowers the adenoma recurrence rate.\n\nSecondary\n\n* Determine the number of adenomas per patient and the size and histology of the adenoma.\n* Assess the interaction between folic acid and alcohol, methionine, and aspirin intake.\n* Assess the interaction between folic acid and pretrial and midtrial folate levels.\n* Assess other complementary biomarkers such as DNA methylation and blood folate level as risk factors for polyp recurrence.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive oral folic acid once daily.\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\nInclusion criteria:\n\n* 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\n* Plan on having an endoscopy within 4 years after initiation of the trial\n* Must release medical records regarding past and any future endoscopies\n\nPATIENT CHARACTERISTICS:\n\nInclusion criteria:\n\n* 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\n\nExclusion criteria:\n\n* Diagnosis of cancer other than non-melanoma skin cancer, or early stage breast or prostate cancer\n* Diagnosis of homocystinemia\n* Diagnosis of pernicious anemia\n* Any gastrointestinal disorder that could lead to a vitamin B12 deficiency\n* Diagnosis of cirrhosis or pancreatitis\n* Diagnosis of epilepsy, Alzheimer's disease, Parkinsonism, and psychiatric disorders that may interfere with normal functioning\n\nPRIOR CONCURRENT THERAPY:\n\nExclusion criteria:\n\n* No prior gastrectomy, total colectomy, or pancreatectomy\n* 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)\n* No concurrent methotrexate or anticonvulsant"}, 'identificationModule': {'nctId': 'NCT00512850', 'briefTitle': 'Folic Acid in Preventing Colorectal Polyps in Patients With Previous Colorectal Polyps', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': "The Nurses' Health Study (NHS) and Health Professionals Follow-Up Study (HPFS) Folic Acid Prevention Trial", 'orgStudyIdInfo': {'id': 'BWH-1999-P-001674/10'}, 'secondaryIdInfos': [{'id': 'CDR0000559650', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'BWH-94-06819', 'type': 'OTHER', 'domain': "Brigham and Women's Hospital Legacy #"}, {'id': 'R01CA067883', 'link': 'https://reporter.nih.gov/quickSearch/R01CA067883', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Folic acid', 'description': 'Folic acid supplement 1g/day', 'interventionNames': ['Dietary Supplement: Folic acid']}, {'type': 'OTHER', 'label': 'Placebo', 'description': 'Placebo pill once per day', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Folic acid', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Intervention group 1g folic acid per day', 'armGroupLabels': ['Folic acid']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'One placebo pill per day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Edward L. Giovannucci, MD, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Dana-Farber/Brigham and Women's Cancer Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': "Dana-Farber/Brigham and Women's Cancer Center", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Edward Giovannucci, MD', 'investigatorFullName': 'Edward Giovannucci', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}