Vitamin D – Part A

Trial Acronym	Vitamin D_CRC
Clinical Area	Cancer
Description	Effects of Vit-D treatment on growth control biomarkers in human primary colorectal tumours (CRT).
Status	Closed

RECRUITMENT

Date Opened to Recruitment	January 2014
Target Recruitment	20
Recruitment to date	8 (correct as of 20th March 2014)

TRIAL DESIGN

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.

CHIEF INVESTIGATOR (CI)

Chief Investigator

Professor Charles Campbell / Dr Richard Wilson

SPONSOR(s) & FUNDER(s)

Sponsor	Belfast Health and Social Care Trust and Queen’s University Belfast
Funder	Cancer Research UK