A Trial of Calcium and Vitamin D for the Prevention of Colorectal Adenomas
Baron JA, Barry EL, Mott LA, Rees JR, Sandler RS, Snover DC, Bostick RM, Ivanova A, Cole BF, Ahnen DJ, Beck GJ, Bresalier RS, Burke CA, Church TR, Cruz-Correa M, Figueiredo JC, Goodman M, Kim AS, Robertson DJ, Rothstein R, Shaukat A, Seabrook ME, Summers RW
The New England journal of medicine · 241 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Cancer Institute
- Gobierno
- National Institute of Diabetes and Digestive and Kidney Diseases
- Gobierno
- NCI NIH HHS
- Gobierno
- NIDDK NIH HHS
- Subvenciones
- National Institute of Diabetes and Digestive and Kidney Diseases (P30 DK056338); National Cancer Institute (P30CA023108); National Cancer Institute (R01CA098286); National Cancer Institute (CA098286)
Según 4 financiadores declarados.
Publicación
- Publicado
- 2015-10-14 · N Engl J Med · vol. 373 · número 16 · págs. 1519–1530
- Editorial
- Massachusetts Medical Society
- Citado
- 316 citas · más que el 100% de estudios similares · 27.8× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 26 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Vitamin D Research Studies · Colorectal Cancer Screening and Detection · Nutritional Studies and Diet
- Palabras clave
- colorectal adenoma, vitamin D3 supplementation, calcium supplementation, chemoprevention, recurrent adenoma, advanced adenoma, serum 25-hydroxyvitamin D, colorectal neoplasia, surveillance colonoscopy
- MeSH
- humans, adenoma, colorectal neoplasms, calcium, vitamins, vitamin d, treatment failure, drug therapy, combination, risk, double-blind method, dietary supplements, aged, middle aged, female, male
23 autores
- John A. Baron🇺🇸University of North Carolina at Chapel Hill; Dartmouth–Hitchcock Medical Center
- Elizabeth L. Barry
- Leila A. Mott
- Judy R. Rees
- Robert S. Sandler
- Dale C. Snover🇺🇸Fairview Southdale Hospital
- Roberd M. Bostick🇺🇸Emory University; Winship Cancer Institute
- Anastasia Ivanova🇺🇸University of North Carolina at Chapel Hill
- Bernard F. Cole🇺🇸University of Vermont
- Dennis J. Ahnen🇺🇸Cleveland Clinic; University of Colorado Denver
- Gerald J. Beck🇺🇸Cleveland Clinic
- Robert S. Bresalier🇺🇸The University of Texas MD Anderson Cancer Center
- Carol Ann Burke🇺🇸Cleveland Clinic
- Timothy R. Church🇺🇸University of Minnesota
- Marcia Cruz–Correa🇵🇷University of Puerto Rico, Medical Sciences Campus; University of Puerto Rico System
- Jane C. Figueiredo🇺🇸University of Southern California
- Michael Moses Goodman🇺🇸Emory University; Winship Cancer Institute
- Adam S. Kim🇺🇸MNGI Digestive Health
- Douglas J. Robertson🇺🇸Dartmouth–Hitchcock Medical Center; White River Junction VA Medical Center
- Richard Ira Rothstein🇺🇸Dartmouth–Hitchcock Medical Center
- Aasma Shaukat🇺🇸University of Minnesota
- March E. Seabrook
- Robert W. Summers🇺🇸University of Iowa
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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