A trial of calcium and vitamin D for the prevention of colorectal adenomas
Open accessAbstract
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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Deciding how to balance external and internal validity is a challenge for many trials and is particularly salient for trials of digital health interventions.
“Deciding how to balance external and internal validity is a challenge for many trials 52, but is particularly salient for trials of DHI.”
From Evaluating Digital Health Interventions (2016) · cites this paper as [52]
There are real questions about how well approaches developed to reduce bias in drug trials translate to trials of complex interventions in general and digital interventions in particular.
“However, there are real questions as to how well approaches developed to reduce bias in drug trials translate to trials of complex interventions in general 52 and to digital interventions in particular, including concerns about the degree to which design features that enhance internal validity jeopardise external validity.”
From Evaluating Digital Health Interventions (2016) · cites this paper as [52]
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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
- 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 › Pathology and Forensic Medicine › 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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