Effectiveness of High Dose Vitamin D Supplementation in Stage III Colorectal Cancer
NCT ID: NCT02603757
Last Updated: 2020-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2016-03-31
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Standard-dose of 2,000 IU Vitamin D3, daily
cholecalciferol
2,000 IU of Vitamin D3 daily and 50,000 IU Vitamin D3 daily
Group B
Higher-dose of 50,000 IU of Vitamin D3, weekly
cholecalciferol
2,000 IU of Vitamin D3 daily and 50,000 IU Vitamin D3 daily
Interventions
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cholecalciferol
2,000 IU of Vitamin D3 daily and 50,000 IU Vitamin D3 daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to stop herbal medications as directed by physician
* Willing to stop current supplemental Vitamin D (Multivitamin with Vitamin D component is acceptable)
* Willing to travel to Legacy Health/OHSU facility if necessary
* Agree to attend study visits outside of standard of care visits, if necessary
* Diagnosed with stage III colon or stage II/III rectal cancer that will receive neoadjuvant or adjuvant chemotherapy but have not yet started
* Baseline serum Vitamin D level below 52 ng/ml
Exclusion Criteria
* Colon cancer stages I-II and IV or Rectal cancer stage I or IV
* Patients who do not undergo chemotherapy
* Patients with prior chemotherapy for this cancer
* 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
* Unable to comply with protocol
* Unable to provide written informed consent
* Unwilling or unable to stop oral supplemental Vitamin D
* Patients taking high-dose Vitamin D supplementation (50,000 IU weekly) prior to enrollment
* Patients with Vitamin D levels above 52 ng/ml at baseline testing
* Patients with hypercalcemia and/or any condition resulting in malabsorption
* Investigator does not believe study participation, for any reason, is in the best interest of the patient
18 Years
99 Years
ALL
No
Sponsors
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Legacy Health System
OTHER
Responsible Party
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Eric Anderson
Principal Investigator
Principal Investigators
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Eric C Anderson, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Legacy Mount Hood Medical Center
Gresham, Oregon, United States
Legacy Good Samaritan Medical Center
Portland, Oregon, United States
Legacy Meridian Park Medical Center
Tualatin, Oregon, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Morgan SL, Weinsier RL. Fundamentals of clinical nutrition, Mosby, St. Louis 1998. p.3
Other Identifiers
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Vitamin D & Colorectal Cancer
Identifier Type: -
Identifier Source: org_study_id
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