Effect of Vitamin D and Calcium Supplementation on Cancer Incidence in Older Women: A Randomized Clinical Trial
Lappe J, Watson P, Travers-Gustafson D, Recker R, Garland C, Gorham E, Baggerly K, McDonnell SL
JAMA · 180 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
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
- 2017-03-28 · JAMA · vol. 317 · número 12 · pág. 1234
- Editorial
- American Medical Association
- Citado
- 247 citas · más que el 100% de estudios similares · 25.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 36 trabajos
- Acceso
- De pago
- Áreas de investigación
- Vitamin D Research Studies · Vitamin C and Antioxidants Research · Cancer Risks and Factors
- Palabras clave
- Medicine, Vitamin D and neurology, Incidence (geometry), Calcium supplementation, Calcium, Cancer, Internal medicine, Cancer incidence, Physiology, Gerontology
- MeSH
- humans, neoplasms, osteoporosis, postmenopausal, kidney calculi, hypercalcemia, calcium, cholecalciferol, vitamins, vitamin d, incidence, proportional hazards models, double-blind method, sample size, time factors, aged, middle aged, nebraska, female, intention to treat analysis, kaplan-meier estimate
8 autores
- Joan M. Lappe🇺🇸 · autor de correspondenciaCreighton University
- Patrice A. Watson🇺🇸Creighton University
- Dianne Travers‐Gustafson🇺🇸Creighton University
- Robert R. Recker🇺🇸Creighton University
- Cedric F. Garland🇺🇸University of California San Diego
- Edward Doerr Gorham🇺🇸University of California San Diego
- Keith Baggerly🇺🇸The University of Texas MD Anderson Cancer Center
- Sharon L. McDonnell🇺🇸GrassrootsHealth
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
Evidence suggests that low vitamin D status may increase the risk of cancer.
Objective
To determine if dietary supplementation with vitamin D3 and calcium reduces the risk of cancer among older women.
Design, setting, and participants
A 4-year, double-blind, placebo-controlled, population-based randomized clinical trial in 31 rural counties (June 24, 2009, to August 26, 2015-the final date of follow-up). A total of 2303 healthy postmenopausal women 55 years or older were randomized, 1156 to the treatment group and 1147 to the placebo group. Duration of treatment was 4 years.
Interventions
The treatment group (vitamin D3 + calcium group) received 2000 IU/d of vitamin D3 and 1500 mg/d of calcium; the placebo group received identical placebos.
Main outcomes and measures
The primary outcome was the incidence of all-type cancer (excluding nonmelanoma skin cancers), which was evaluated using Kaplan-Meier survival analysis and proportional hazards modeling.
Results
Among 2303 randomized women (mean age, 65.2 years [SD, 7.0]; mean baseline serum 25-hydroxyvitamin D level, 32.8 ng/mL [SD, 10.5]), 2064 (90%) completed the study. At year 1, serum 25-hydroxyvitamin D levels were 43.9 ng/mL in the vitamin D3 + calcium group and 31.6 ng/mL in the placebo group. A new diagnosis of cancer was confirmed in 109 participants, 45 (3.89%) in the vitamin D3 + calcium group and 64 (5.58%) in the placebo group (difference, 1.69% [95% CI, -0.06% to 3.46%]; P = .06). Kaplan-Meier incidence over 4 years was 0.042 (95% CI, 0.032 to 0.056) in the vitamin D3 + calcium group and 0.060 (95% CI, 0.048 to 0.076) in the placebo group; P = .06. In unadjusted Cox proportional hazards regression, the hazard ratio was 0.70 (95% CI, 0.47 to 1.02). Adverse events potentially related to the study included renal calculi (16 participants in the vitamin D3 + calcium group and 10 in the placebo group), and elevated serum calcium levels (6 in the vitamin D3 + calcium group and 2 in the placebo group).
Conclusions and relevance
Among healthy postmenopausal older women with a mean baseline serum 25-hydroxyvitamin D level of 32.8 ng/mL, supplementation with vitamin D3 and calcium compared with placebo did not result in a significantly lower risk of all-type cancer at 4 years. Further research is necessary to assess the possible role of vitamin D in cancer prevention.
Trial registration
clinicaltrials.gov Identifier: NCT01052051.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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