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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
2,000 IU of Vitamin D3 daily and 50,000 IU Vitamin D3 daily
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
Increase in serum Vitamin D3 level during chemotherapy in the active supplementation group compared to the control group.
Time frame: 1 year
Relapse-free survival (RFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
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