Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-27 @ 9:57 PM
Study NCT ID:
NCT00870961
Status:
TERMINATED
Last Update Posted:
2013-09-16
First Post:
2009-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Supplement in Preventing Colon Cancer in African Americans With Colon Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D018256', 'term': 'Adenomatous Polyps'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'PI changed institutions and accrual was not completed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-13', 'studyFirstSubmitDate': '2009-03-26', 'studyFirstSubmitQcDate': '2009-03-26', 'lastUpdatePostDateStruct': {'date': '2013-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of compliance as assessed at 6 months', 'timeFrame': 'Following 6 months of study treatment'}, {'measure': 'Rate of accrual', 'timeFrame': 'After accrual goal is reached'}], 'secondaryOutcomes': [{'measure': 'Changes in pre- and post-treatment vitamin D levels', 'timeFrame': 'At baseline and following completion of study treatment'}, {'measure': 'Correlation of vitamin D levels with vitamin D modifiers (e.g., levels of skin pigmentation, dietary vitamin D intake, and sun exposure)', 'timeFrame': 'After completion of study treatment & final colonic biopsy'}]}, 'conditionsModule': {'keywords': ['colon cancer', 'rectal cancer', 'adenomatous polyp'], 'conditions': ['Colorectal Cancer', 'Precancerous Condition']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of vitamin D may keep colorectal cancer from forming in patients with colon polyps.\n\nPURPOSE: This randomized phase I trial is studying a vitamin D supplement to see how well it works compared with a placebo in preventing colorectal cancer in African Americans with colon polyps.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To determine the accrual rate of African Americans with adenomatous polyps to a 6-month randomized intervention trial comprising supplementation with either cholecalciferol (vitamin D3) or placebo.\n* To determine the compliance rates in patients treated with these regimens.\n\nSecondary\n\n* To compare changes in pre- and post-treatment vitamin D levels in patients treated with these regimens.\n* To correlate vitamin D levels with vitamin D modifiers, such as levels of skin pigmentation, dietary vitamin D intake, and sun exposure in this patient population.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\n* Arm I: Patients receive oral cholecalciferol (vitamin D3) supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive oral placebo supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.\n\nPatients complete questionnaires about demographics, dietary vitamin D intake, personal history (e.g., ancestry, alcohol and tobacco intake, occupation, height, and weight), medical history (e.g., personal and family history of colorectal cancer and polyps), and ultraviolet radiation exposure.\n\nBlood samples are collected at baseline and at 6 months for correlative laboratory studies. Blood samples are analyzed for vitamin D levels by enzyme immunoassay. Patients also undergo assessment of skin pigmentation in sunprotected and sunexposed areas of skin by reflectance spectrometry at baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenomatous polyp\n\n * At least 1 adenoma\n* Self-identified as an African American AND undergoing screening or diagnostic colonoscopy at the University of Chicago\n* No history of colon or rectal cancer or hereditary or familial colon cancer (e.g., hereditary non-polyposis colon cancer or familial adenomatous polyposis)\n\nPATIENT CHARACTERISTICS:\n\n* Total bilirubin normal\n* AST and ALT ≤ 2.5 times upper limit of normal\n* Creatinine normal\n* Albumin ≥ 3.0 mg/dL\n* Baseline serum calcium level normal\n* Not pregnant\n* No history of thyroid disease\n* No history of renal stones\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No other concurrent vitamin D intake'}, 'identificationModule': {'nctId': 'NCT00870961', 'briefTitle': 'Vitamin D Supplement in Preventing Colon Cancer in African Americans With Colon Polyps', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Vitamin D Intervention For Colon Cancer Prevention In African-Americans-A Pilot Study', 'orgStudyIdInfo': {'id': 'NU 08I3'}, 'secondaryIdInfos': [{'id': 'P30CA060553', 'link': 'https://reporter.nih.gov/quickSearch/P30CA060553', 'type': 'NIH'}, {'id': 'NU-08I3'}, {'id': 'STU00005964', 'type': 'OTHER', 'domain': 'Northwestern University IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive oral cholecalciferol (vitamin D3) supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Dietary Supplement: cholecalciferol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II', 'description': 'Patients receive oral placebo supplementation daily for up to 6 months in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'cholecalciferol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Given orally', 'armGroupLabels': ['Arm I']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Given orally', 'armGroupLabels': ['Arm II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611-3013', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center at Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Cancer Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Halla Nimeiri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Robert H. Lurie Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}