Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-06-20 @ 9:51 PM
Study NCT ID:
NCT02603757
Status:
COMPLETED
Last Update Posted:
2020-10-01
First Post:
2015-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of High Dose Vitamin D Supplementation in Stage III Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'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'}]}, '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-29', 'studyFirstSubmitDate': '2015-11-09', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in serum Vitamin D3 level during chemotherapy in the active supplementation group compared to the control group.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Relapse-free survival (RFS)', 'timeFrame': '5 years'}, {'measure': 'Overall survival (OS)', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin D'], 'conditions': ['Colon Cancer', 'Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '20945439', 'type': 'BACKGROUND', 'citation': 'Fiscella K, Winters P, Tancredi D, Hendren S, Franks P. Racial disparity in death from colorectal cancer: does vitamin D deficiency contribute? Cancer. 2011 Mar 1;117(5):1061-9. doi: 10.1002/cncr.25647. Epub 2010 Oct 13.'}, {'pmid': '25002714', 'type': 'BACKGROUND', 'citation': 'Zgaga L, Theodoratou E, Farrington SM, Din FV, Ooi LY, Glodzik D, Johnston S, Tenesa A, Campbell H, Dunlop MG. Plasma vitamin D concentration influences survival outcome after a diagnosis of colorectal cancer. J Clin Oncol. 2014 Aug 10;32(23):2430-9. doi: 10.1200/JCO.2013.54.5947. Epub 2014 Jul 7.'}, {'pmid': '21422438', 'type': 'BACKGROUND', 'citation': 'Ng K, Sargent DJ, Goldberg RM, Meyerhardt JA, Green EM, Pitot HC, Hollis BW, Pollak MN, Fuchs CS. Vitamin D status in patients with stage IV colorectal cancer: findings from Intergroup trial N9741. J Clin Oncol. 2011 Apr 20;29(12):1599-606. doi: 10.1200/JCO.2010.31.7255. Epub 2011 Mar 21.'}, {'pmid': '21774589', 'type': 'BACKGROUND', 'citation': "Brunner RL, Wactawski-Wende J, Caan BJ, Cochrane BB, Chlebowski RT, Gass ML, Jacobs ET, LaCroix AZ, Lane D, Larson J, Margolis KL, Millen AE, Sarto GE, Vitolins MZ, Wallace RB. The effect of calcium plus vitamin D on risk for invasive cancer: results of the Women's Health Initiative (WHI) calcium plus vitamin D randomized clinical trial. Nutr Cancer. 2011;63(6):827-41. doi: 10.1080/01635581.2011.594208. Epub 2011 Jul 20."}, {'pmid': '22493367', 'type': 'BACKGROUND', 'citation': 'Fakih MG, Andrews C, McMahon J, Muindi JR. A prospective clinical trial of cholecalciferol 2000 IU/day in colorectal cancer patients: evidence of a chemotherapy-response interaction. Anticancer Res. 2012 Apr;32(4):1333-8.'}, {'pmid': '19258546', 'type': 'BACKGROUND', 'citation': 'Fedirko V, Bostick RM, Flanders WD, Long Q, Shaukat A, Rutherford RE, Daniel CR, Cohen V, Dash C. Effects of vitamin D and calcium supplementation on markers of apoptosis in normal colon mucosa: a randomized, double-blind, placebo-controlled clinical trial. Cancer Prev Res (Phila). 2009 Mar;2(3):213-23. doi: 10.1158/1940-6207.CAPR-08-0157. Epub 2009 Mar 3.'}, {'pmid': '16007183', 'type': 'BACKGROUND', 'citation': 'Fernandez-Garcia NI, Palmer HG, Garcia M, Gonzalez-Martin A, del Rio M, Barettino D, Volpert O, Munoz A, Jimenez B. 1alpha,25-Dihydroxyvitamin D3 regulates the expression of Id1 and Id2 genes and the angiogenic phenotype of human colon carcinoma cells. Oncogene. 2005 Sep 29;24(43):6533-44. doi: 10.1038/sj.onc.1208801.'}, {'pmid': '20056649', 'type': 'BACKGROUND', 'citation': 'Fedirko V, Bostick RM, Long Q, Flanders WD, McCullough ML, Sidelnikov E, Daniel CR, Rutherford RE, Shaukat A. Effects of supplemental vitamin D and calcium on oxidative DNA damage marker in normal colorectal mucosa: a randomized clinical trial. Cancer Epidemiol Biomarkers Prev. 2010 Jan;19(1):280-91. doi: 10.1158/1055-9965.EPI-09-0448.'}, {'pmid': '22576645', 'type': 'BACKGROUND', 'citation': 'Bee CR, Sheerin DV, Wuest TK, Fitzpatrick DC. Serum vitamin D levels in orthopaedic trauma patients living in the northwestern United States. J Orthop Trauma. 2013 May;27(5):e103-6. doi: 10.1097/BOT.0b013e31825cf8fb.'}, {'type': 'BACKGROUND', 'citation': 'Morgan SL, Weinsier RL. Fundamentals of clinical nutrition, Mosby, St. Louis 1998. p.3'}]}, 'descriptionModule': {'briefSummary': "This is a pilot study to test whether there is an association between baseline Vitamin D levels, Vitamin D supplementation and survival in patients with stage III colon and stage II/III rectal cancer receiving chemotherapy. 70 patients with colon stage III or rectal stage II or III cancer that require chemotherapy will be screened and 60 patients will be enrolled. Patients will be randomized to standard dose (2000 IU daily) or high-dose (50,000 IU weekly) Vitamin D supplementation for 1 year after initiation of chemotherapy. Patients' Vitamin D levels will be checked throughout supplementation then followed for 5 years with occasional Vitamin D testing and surveying in order to collect information on recurrence and survival outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age\n* Willing to stop herbal medications as directed by physician\n* Willing to stop current supplemental Vitamin D (Multivitamin with Vitamin D component is acceptable)\n* Willing to travel to Legacy Health/OHSU facility if necessary\n* Agree to attend study visits outside of standard of care visits, if necessary\n* Diagnosed with stage III colon or stage II/III rectal cancer that will receive neoadjuvant or adjuvant chemotherapy but have not yet started\n* Baseline serum Vitamin D level below 52 ng/ml\n\nExclusion Criteria:\n\n* ≤ 18 years of age\n* Colon cancer stages I-II and IV or Rectal cancer stage I or IV\n* Patients who do not undergo chemotherapy\n* Patients with prior chemotherapy for this cancer\n* No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer for which the patient has been disease-free for \\> 3 years\n* Unable to comply with protocol\n* Unable to provide written informed consent\n* Unwilling or unable to stop oral supplemental Vitamin D\n* Patients taking high-dose Vitamin D supplementation (50,000 IU weekly) prior to enrollment\n* Patients with Vitamin D levels above 52 ng/ml at baseline testing\n* Patients with hypercalcemia and/or any condition resulting in malabsorption\n* Investigator does not believe study participation, for any reason, is in the best interest of the patient'}, 'identificationModule': {'nctId': 'NCT02603757', 'briefTitle': 'Effectiveness of High Dose Vitamin D Supplementation in Stage III Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Legacy Health System'}, 'officialTitle': 'Prospective Pilot Study to Assess the Effectiveness of Vitamin D Supplementation for Patients Requiring Chemotherapy for Stage III Colorectal Cancer', 'orgStudyIdInfo': {'id': 'Vitamin D & Colorectal Cancer'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Standard-dose of 2,000 IU Vitamin D3, daily', 'interventionNames': ['Dietary Supplement: cholecalciferol']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Higher-dose of 50,000 IU of Vitamin D3, weekly', 'interventionNames': ['Dietary Supplement: cholecalciferol']}], 'interventions': [{'name': 'cholecalciferol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Vitamin D3'], 'description': '2,000 IU of Vitamin D3 daily and 50,000 IU Vitamin D3 daily', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97030', 'city': 'Gresham', 'state': 'Oregon', 'country': 'United States', 'facility': 'Legacy Mount Hood Medical Center', 'geoPoint': {'lat': 45.49818, 'lon': -122.43148}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Legacy Good Samaritan Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97062', 'city': 'Tualatin', 'state': 'Oregon', 'country': 'United States', 'facility': 'Legacy Meridian Park Medical Center', 'geoPoint': {'lat': 45.38401, 'lon': -122.76399}}], 'overallOfficials': [{'name': 'Eric C Anderson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Legacy Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eric Anderson', 'investigatorAffiliation': 'Legacy Health System'}}}}