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Ensayo controlado aleatorizado2006Financiación no declarada

Calcium plus vitamin D supplementation and the risk of colorectal cancer

Wactawski-Wende J, Kotchen JM, Anderson GL, Assaf AR, Brunner RL, O'Sullivan MJ, Margolis KL, Ockene JK, Phillips L, Pottern L, Prentice RL, Robbins J, Rohan TE, Sarto GE, Sharma S, Stefanick ML, Van Horn L, Wallace RB, Whitlock E, Bassford T, Beresford SA, Black HR, Bonds DE, Brzyski RG, Caan B, Chlebowski RT, Cochrane B, Garland C, Gass M, Hays J, Heiss G, Hendrix SL, Howard BV, Hsia J, Hubbell FA, Jackson RD, Johnson KC, Judd H, Kooperberg CL, Kuller LH, LaCroix AZ, Lane DS, Langer RD, Lasser NL, Lewis CE, Limacher MC, Manson JE, Women's Health Initiative Investigators

The New England journal of medicine · 680 citas

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Financiación no declarada

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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 no declarada

Publicación

Publicado
2006-02-15 · N Engl J Med · vol. 354 · número 7 · págs. 684–696
Editorial
Massachusetts Medical Society
Citado
980 citas · más que el 100% de estudios similares · 52.1× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
46 trabajos
Acceso
Lectura gratuita
Áreas de investigación
Vitamin D Research Studies · Nutritional Studies and Diet · Colorectal Cancer Screening and Detection
Palabras clave
calcium supplementation, vitamin D supplementation, colorectal cancer, primary prevention, postmenopausal women, Women's Health Initiative, colorectal cancer incidence, 25-hydroxyvitamin D, calcium carbonate, vitamin D3
MeSH
humans, adenocarcinoma, colorectal neoplasms, colonic polyps, calcium carbonate, calcium, vitamin d, drug combinations, incidence, proportional hazards models, follow-up studies, double-blind method, postmenopause, aged, middle aged, female

47 autores

  • Jean Wactawski‐Wende🇺🇸University at Buffalo, State University of New York
  • Jane Morley Kotchen🇺🇸University at Buffalo, State University of New York
  • Garnet L. Anderson🇺🇸University at Buffalo, State University of New York
  • Annlouise R. Assaf🇺🇸University at Buffalo, State University of New York
  • Robert L. Brunner🇺🇸University at Buffalo, State University of New York
  • Mary Jo O’Sullivan🇺🇸University at Buffalo, State University of New York
  • Karen L. Margolis🇺🇸University at Buffalo, State University of New York
  • Judith K. Ockene🇺🇸University at Buffalo, State University of New York
  • Lawrence S. Phillips🇺🇸University at Buffalo, State University of New York
  • Linda M. Pottern🇺🇸University at Buffalo, State University of New York
  • Ross L. Prentice🇺🇸University at Buffalo, State University of New York
  • John A. Robbins🇺🇸University at Buffalo, State University of New York
  • Thomas E. Rohan🇺🇸University at Buffalo, State University of New York
  • Gloria E. Sarto🇺🇸University at Buffalo, State University of New York
  • Santosh Sharma🇺🇸University at Buffalo, State University of New York
  • Marcia L. Stefanick🇺🇸University at Buffalo, State University of New York
  • Linda Van Horn🇺🇸University at Buffalo, State University of New York
  • Robert B. Wallace🇺🇸University at Buffalo, State University of New York
  • Evelyn P Whitlock🇺🇸University at Buffalo, State University of New York
  • Tamsen L. Bassford🇺🇸University at Buffalo, State University of New York
  • Shirley A.A. Beresford🇺🇸University at Buffalo, State University of New York
  • Henry Richard Black🇺🇸University at Buffalo, State University of New York
  • Denise E. Bonds🇺🇸University at Buffalo, State University of New York
  • Robert G. Brzyski🇺🇸University at Buffalo, State University of New York
  • Bette Jane Caan🇺🇸University at Buffalo, State University of New York
  • Rowan T. Chlebowski🇺🇸University at Buffalo, State University of New York
  • Barbara Cochrane🇺🇸University at Buffalo, State University of New York
  • Cedric F. Garland🇺🇸University at Buffalo, State University of New York
  • Margery L S Gass🇺🇸University at Buffalo, State University of New York
  • Jennifer Hays-Grudo🇺🇸University at Buffalo, State University of New York
  • Gerardo M HEISS🇺🇸University at Buffalo, State University of New York
  • Susan L. Hendrix🇺🇸University at Buffalo, State University of New York
  • Barbara V. Howard🇺🇸University at Buffalo, State University of New York
  • Judith A. Hsia🇺🇸University at Buffalo, State University of New York
  • F. Allan Hubbell🇺🇸University at Buffalo, State University of New York
  • Rebecca D. Jackson🇺🇸University at Buffalo, State University of New York
  • Karen Johnson🇺🇸University at Buffalo, State University of New York
  • Howard Judd🇺🇸University at Buffalo, State University of New York
  • Charles L Kooperberg🇺🇸University at Buffalo, State University of New York
  • Lewis H. Kuller🇺🇸University at Buffalo, State University of New York
  • Andrea Z. LaCroix🇺🇸University at Buffalo, State University of New York
  • Dorothy S. Lane🇺🇸University at Buffalo, State University of New York
  • Robert D. Langer🇺🇸University at Buffalo, State University of New York
  • Norman L. Lasser🇺🇸University at Buffalo, State University of New York
  • Cora Elizabeth Lewis🇺🇸University at Buffalo, State University of New York
  • Marian C. Limacher🇺🇸University at Buffalo, State University of New York
  • JoAnn E. Manson🇺🇸University at Buffalo, State University of New York

Resumen

El texto original del estudio, en el idioma en que se publicó.

Background

Higher intake of calcium and vitamin D has been associated with a reduced risk of colorectal cancer in epidemiologic studies and polyp recurrence in polyp-prevention trials. However, randomized-trial evidence that calcium with vitamin D supplementation is beneficial in the primary prevention of colorectal cancer is lacking.

Methods

We conducted a randomized, double-blind, placebo-controlled trial involving 36,282 postmenopausal women from 40 Women's Health Initiative centers: 18,176 women received 500 mg of elemental calcium as calcium carbonate with 200 IU of vitamin D3 [corrected] twice daily (1000 mg of elemental calcium and 400 IU of vitamin D3) and 18,106 received a matching placebo for an average of 7.0 years. The incidence of pathologically confirmed colorectal cancer was the designated secondary outcome. Baseline levels of serum 25-hydroxyvitamin D were assessed in a nested case-control study.

Results

The incidence of invasive colorectal cancer did not differ significantly between women assigned to calcium plus vitamin D supplementation and those assigned to placebo (168 and 154 cases; hazard ratio, 1.08; 95 percent confidence interval, 0.86 to 1.34; P=0.51), and the tumor characteristics were similar in the two groups. The frequency of colorectal-cancer screening and abdominal symptoms was similar in the two groups. There were no significant treatment interactions with baseline characteristics.

Conclusions

Daily supplementation of calcium with vitamin D for seven years had no effect on the incidence of colorectal cancer among postmenopausal women. The long latency associated with the development of colorectal cancer, along with the seven-year duration of the trial, may have contributed to this null finding. Ongoing follow-up will assess the longer-term effect of this intervention. (ClinicalTrials.gov number, NCT00000611.).

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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