At a glance
ClinicalIndex Comparison Record- ✓One or more histologically verified adenoma at least 2 mm removed from large bowel with entire colon examined by colonoscopy and documented polyp-free within 120 days of study entry
- ✓Anticipated colonoscopic follow-up at 3 or 5 years after qualifying colonoscopy
- ✓Age 45–75 years at enrollment
- ✓Blood calcium within normal range
- ✕Any diagnosis of invasive carcinoma of the large bowel
- ✕Familial colorectal cancer syndromes (FAP, HNPCC, hamartomatous polyposis)
- ✕Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- ✕Chronic intestinal malabsorption syndromes in past 5 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Vitamin D/Calcium Polyp Prevention Study
In Brief
A Phase 3 clinical trial evaluating Calcium Carbonate, Vitamin D3, and 1 other intervention for Colorectal Cancer and 2 related conditions. Completed, enrolled 2,813 participants across 11 sites in 2 countries.
Detailed Summary
Extensive experimental and observational data suggest that intake of calcium and of vitamin D exert protective effects on colorectal neoplasia. Building on their previous work, the investigators will investigate the chemopreventive effect of vitamin D in the large bowel, to study whether calcium with vitamin D is more effective than calcium alone, and to confirm their positive finding regarding calcium. The goal of this study is the development of chemopreventive combinations that will reduce risk of colorectal neoplasia sufficiently to permit the lengthening of surveillance intervals in most patients and to clarify important issues regarding the mechanisms of colorectal carcinogenesis and chemoprevention.
Study Details
Timeline
Interventions
3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet
1000 IU/daily; two tablets per day; 500 IU per tablet
placebo; two tablets per day