Cited by 315Vitamin D Research StudiesColorectal Cancer Screening and DetectionNutritional Studies and Diet

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

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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.·2015·New England Journal of Medicine

DOI 10.1056/nejmoa1500409PMC PMC4643064

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Abstract

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 D3 (1000 IU), calcium as carbonate (1200 mg), both, or neither in a partial 2×2 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 D3 (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. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT00153816.).

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Authors: Baron, J. A., Barry, E. L., Mott, L. A., Rees, J. R., Sandler, R. S., Snover, D. C., Bostick, R. M., Ivanova, A., Cole, B. F., Ahnen, D. J., Beck, G. J., Bresalier, R. S., Burke, C. A., Church, T. R., Cruz-Correa, M., Figueiredo, J. C., Goodman, M., Kim, A. S., Robertson, D. J., Rothstein, R., Shaukat, A., Seabrook, M. E., & Summers, R. W.
Affiliations: University of North Carolina at Chapel Hill (US)
Fairview Southdale Hospital (US)
Emory University (US)
University of Vermont (US)
Cleveland Clinic (US)
The University of Texas MD Anderson Cancer Center (US)
University of Minnesota (US)
University of Southern California (US)
MNGI Digestive Health (US)
Dartmouth–Hitchcock Medical Center (US)
University of Iowa (US)
ORCID: 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.
Figueiredo, Jane C.
Goodman, Michael
Kim, Adam S.
Robertson, Douglas J.
Shaukat, Aasma
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2015-10-15
Volume: 373
Issue: 16
Pages: 1519-1530
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1500409
PMC: PMC4643064
OpenAlex: W2259846353
Cited by: 315
References: 26
Citations by year: 2026: 8 · 2025: 16 · 2024: 15 · 2023: 26 · 2022: 29 · 2021: 32 · 2020: 29 · 2019: 39 · 2018: 36 · 2017: 33 · 2016: 49 · 2015: 3
FWCI: 32.01
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: National Cancer Institute (R01CA098286, CA098286, P30CA023108)
National Institute of Diabetes and Digestive and Kidney Diseases (P30DK056338)
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Vitamin D Research Studies
Health Sciences › Medicine › Oncology › Colorectal Cancer Screening and Detection
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutritional Studies and Diet
Keywords: colorectal adenoma, vitamin D3 supplementation, calcium supplementation, chemoprevention, recurrent adenoma, advanced adenoma, serum 25-hydroxyvitamin D, colorectal neoplasia, surveillance colonoscopy
MeSH terms: Adenoma, Aged, Calcium, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Risk, Vitamin D, Vitamins, Colorectal Neoplasms, Treatment Failure, Dietary Supplements

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

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