Clinical Trial: Study of Calcium Plus Vitamin D Supplementation in Prevention of Colorectal Adenomas Recurrence

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Calcium Plus Vitamin D Supplementation in Prevention of Colorectal Adenomas Recurrence:a Prospective, Randomized, Placebo-controlled, Multicenter Clinical Trial

Brief Summary: Calcium plus vitamin D may be effective in the prevention of colorectal adenoma recurrence. The aim of this study is to investigate the effect of supplementation with calcium plus vitamin D on the recurrence of colorectal adenomas.

Detailed Summary: Colorectal adenomas are well-known to be precancerous lesions that develop into colorectal cancers on the basis of the adenoma-carcinoma sequence. The effects of screening for colorectal adenomas and removing precancerous lesions on the prevention of colorectal cancer have been established. Because of the high recurrence rates of colorectal adenomas in patients who have undergone polypectomy, the potential chemopreventive agents that may reduce the risk of colorectal adenoma recurrence need to be investigated. Since laboratory and epidemiologic evidence suggests that calcium or vitamin D may help prevent colorectal adenomas, we conduct a randomized, placebo-controlled, prospective clinical trial to study the effect and safety of calcium plus vitamin D supplementation in prevention of colorectal adenomas recurrence.
Sponsor: Shanghai Jiao Tong University School of Medicine

Current Primary Outcome: The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after calcium plus vitamin D intervention. [ Time Frame: 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The recurrence rates of advanced colorectal adenoma (A-CRA) after calcium plus vitamin D intervention. [ Time Frame: 3 years ]

Original Secondary Outcome: Same as current

Information By: Shanghai Jiao Tong University School of Medicine

Dates:
Date Received: May 17, 2014
Date Started: March 2014
Date Completion: February 2019
Last Updated: May 17, 2014
Last Verified: May 2014