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Effectiveness of High Dose Vitamin D Supplementation in Stage III Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02603757
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Eric Anderson, Legacy Health System

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colon Cancer Rectal Cancer Dietary Supplement: cholecalciferol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Pilot Study to Assess the Effectiveness of Vitamin D Supplementation for Patients Requiring Chemotherapy for Stage III Colorectal Cancer
Study Start Date : March 2016
Actual Primary Completion Date : June 2020
Actual Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
Standard-dose of 2,000 IU Vitamin D3, daily
Dietary Supplement: cholecalciferol
2,000 IU of Vitamin D3 daily and 50,000 IU Vitamin D3 daily
Other Name: Vitamin D3

Experimental: Group B
Higher-dose of 50,000 IU of Vitamin D3, weekly
Dietary Supplement: cholecalciferol
2,000 IU of Vitamin D3 daily and 50,000 IU Vitamin D3 daily
Other Name: Vitamin D3




Primary Outcome Measures :
  1. Increase in serum Vitamin D3 level during chemotherapy in the active supplementation group compared to the control group. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Relapse-free survival (RFS) [ Time Frame: 5 years ]
  2. Overall survival (OS) [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years of age
  • 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:

  • ≤ 18 years of age
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603757


Locations
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United States, Oregon
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Legacy Good Samaritan Medical Center
Portland, Oregon, United States, 97210
Legacy Meridian Park Medical Center
Tualatin, Oregon, United States, 97062
Sponsors and Collaborators
Legacy Health System
Investigators
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Principal Investigator: Eric C Anderson, MD Oregon Health and Science University
Additional Information:
Publications:
Morgan SL, Weinsier RL. Fundamentals of clinical nutrition, Mosby, St. Louis 1998. p.3

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Responsible Party: Eric Anderson, Principal Investigator, Legacy Health System
ClinicalTrials.gov Identifier: NCT02603757    
Other Study ID Numbers: Vitamin D & Colorectal Cancer
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Keywords provided by Eric Anderson, Legacy Health System:
Vitamin D
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents