Vitamin D in Colorectal Chemotherapy Patients

Clinical Trial Title Effectiveness of High Dose Vitamin D Supplementation in Stage III Colorectal Cancer
Trial Status Closed to Enrollment
Start Date 03/30/2016
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Colorectal Cancer
Description 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.
Eligibility Criteria

Inclusion Criteria:

  • > 18 years of age 
  • 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
  • Willing to stop herbal medications as directed by physician
  • Willing to stop current supplemental vitamin D (Multivitamin with vitamin D component is acceptable)

Ineligibility Criteria

  • 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
  • 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

Patients will be randomized to one of two supplementation options. One group will take a 2,000 IU capsule daily and the other group will take 50,000 IU weekly.
IRB Number Legacy IRB
Notes https://clinicaltrials.gov/ct2/show/NCT02603757
Principal Investigator Eric Anderson, MD, PhD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org