NCT02603757

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Legacy Health System · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colon Cancer
• Rectal Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	cholecalciferol	2,000 IU of Vitamin D3 daily and 50,000 IU Vitamin D3 daily

Timeline

• Start date: 2016-03-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2015-11-13
• Last updated: 2020-10-01

Locations

3 sites across 1 country: United States