drugset / Trial / NCT01150877

High Dose Vitamin D Study

NCT01150877

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to investigate the therapeutic effect and the safety of high-dose vitamin D supplementation in metastatic colorectal cancer patients. We propose to supplement metastatic (stage 4) colorectal cancer patients with oral doses of vitamin D to raise serum 25-hydroxy-vitamin D \[25(OH)D\] levels to the high normal range of 200-250 nmol/L. The primary objective of this study is to evaluate the metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer. The secondary objective is to evaluate patient survival with regards to high-dose vitamin D supplementation. Hypothesis: Whereas low doses of vitamin D reportedly play a significant role in prevention of colorectal cancers, do much larger (pharmacological) doses of vitamin D have a significant therapeutic effect against the same kind of cancer?

Timeline

Start
2011-01
Primary completion
2014-04-23
Completion
2014-04-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Vitamin D Other / unclassified Oral

Indications