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