drugset / Trial / NCT00298545

Effect of Vitamin D and Calcium on Genes in the Colon

NCT00298545

Phase 1 Completed 10 enrolled Rockefeller University
RandomizedCrossoverTriple-blindPrevention

Summary

The researchers are involved in a research program to understand how vitamin D and calcium in the diet or as supplements may lower the risk of colorectal polyps and cancer. To that end, the researchers are conducting a study of vitamin D supplementation in which volunteer subjects are provided a Western style diet for 2 separate 4 week periods at the Rockefeller University Hospital. During one of these 4 week inpatient periods, subjects receive calcium supplements and during the other 4 week inpatient period they receive a placebo tablet. The researchers determine changes within the colon as a result of supplementing the vitamin D in the presence of high and low calcium. A more detailed description of the study is provided below.

Timeline

Start
2005-11
Primary completion
2009-05
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Calcium carbonate Other / unclassified 2 g
Comparator Calcitriol Small molecule 0.5 ug Oral