A Trial of Calcium and Vitamin D for the Prevention of Colorectal Adenomas

作者：Baron, John A.^*; Barry, Elizabeth L.; Mott, Leila A.; Rees, Judy R.; Sandler, Robert S.; Snover, Dale C.; Bostick, Roberd M.; Ivanova, Anastasia; Cole, Bernard F.; Ahnen, Dennis J.; Beck, Gerald J.; Bresalier, Robert S.; Burke, Carol A.; Church, Timothy R.; Cruz-Correa, Marcia; Figueiredo, Jane C.; Goodman, Michael; Kim, Adam S.; Robertson, Douglas J.; Rothstein, Richard; Shaukat, Aasma; Seabrook, March E.; Summers, Robert W.

来源：New England Journal of Medicine, 2015, 373(16): 1519-1530.

DOI：10.1056/NEJMoa1500409

• D-RECEPTOR POLYMORPHISMS
• CANCER-RISK
• COLON CARCINOGENESIS
• 25-HYDROXYVITAMIN D
• RANDOMIZED-TRIAL
• SUPPLEMENTATION
• METAANALYSIS
• FRACTURES
• MORTALITY
• MEN

BACKGROUND @@@ Epidemiologic and preclinical data suggest that higher intake and serum levels of vitamin D and higher intake of calcium reduce the risk of colorectal neoplasia. To further study the chemopreventive potential of these nutrients, we conducted a randomized, double-blind, placebo-controlled trial of supplementation with vitamin D, calcium, or both for the prevention of colorectal adenomas. @@@ METHODS @@@ We recruited patients with recently diagnosed adenomas and no known colorectal polyps remaining after complete colonoscopy. We randomly assigned 2259 participants to receive daily vitamin D-3 (1000 IU), calcium as carbonate (1200 mg), both, or neither in a partial 2x2 factorial design. Women could elect to receive calcium plus random assignment to vitamin D or placebo. Follow-up colonoscopy was anticipated to be performed 3 or 5 years after the baseline examinations, according to the endoscopist's recommendation. The primary end point was adenomas diagnosed in the interval from randomization through the anticipated surveillance colonoscopy. @@@ RESULTS @@@ Participants who were randomly assigned to receive vitamin D had a mean net increase in serum 25-hydroxyvitamin D levels of 7.83 ng per milliliter, relative to participants given placebo. Overall, 43% of participants had one or more adenomas diagnosed during follow-up. The adjusted risk ratios for recurrent adenomas were 0.99 (95% confidence interval [CI], 0.89 to 1.09) with vitamin D versus no vitamin D, 0.95 (95% CI, 0.85 to 1.06) with calcium versus no calcium, and 0.93 (95% CI, 0.80 to 1.08) with both agents versus neither agent. The findings for advanced adenomas were similar. There were few serious adverse events. @@@ CONCLUSIONS @@@ Daily supplementation with vitamin D-3 (1000 IU), calcium (1200 mg), or both after removal of colorectal adenomas did not significantly reduce the risk of recurrent colorectal adenomas over a period of 3 to 5 years.

• 出版日期2015-10-15