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

September 29, 2020 updated by: Eric Anderson, Legacy Health System

Prospective Pilot Study to Assess the Effectiveness of Vitamin D Supplementation for Patients Requiring Chemotherapy for Stage III Colorectal Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Legacy Mount Hood Medical Center
      • Portland, Oregon, United States, 97210
        • Legacy Good Samaritan Medical Center
      • Tualatin, Oregon, United States, 97062
        • Legacy Meridian Park Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Vitamin D3

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: 5 years
5 years
Relapse-free survival (RFS)
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Legacy Health System

Investigators

  • Principal Investigator: Eric C Anderson, MD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

November 9, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 13, 2015

Study Record Updates

Last Update Posted (Actual)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 29, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitamin D & Colorectal Cancer

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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