Trial Design |
Part A – Dose Confirmation Study |
Study Aim |
The aim of this phase of the study is to ascertain if the proposed dosing regimen of cholectalciferol (300,000 IU) raises serum25(OH)D levels above the cancer suppressive level of 33ng/ml in 80% of subjects. This phase has two objectives: |
|
Objective one: To ascertain if the proposed dosing regimen of cholecalciferol achieves cancer–suppressive levels of 25(OH)D in CRC patients. |
|
Objective two: To investigate the safety of the cholecalciferol dose in CRC patients. |