Long-term follow-up for mortality and cancer in a randomized placebo-controlled trial of vitamin D(3) and/or calcium (RECORD trial)
Avenell A, MacLennan GS, Jenkinson DJ, McPherson GC, McDonald AM, Pant PR, Grant AM, Campbell MK, Anderson FH, Cooper C, Francis RM, Gillespie WJ, Robinson CM, Torgerson DJ, Wallace WA, RECORD Trial Group
The Journal of clinical endocrinology and metabolism · 180 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
- Organización sin fines de lucro
- Cancer Research UK
- Gobierno
- National Institute for Health and Care Research
- Universidad u hospital
- University of Liverpool
- Universidad u hospital
- University of Aberdeen
- Gobierno
- Medical Research Council
- Gobierno
- National Institute for Health Research (NIHR)
- Gobierno
- Chief Scientist Office
- Subvenciones
- National Institute for Health and Care Research (NF-SI-0508-10082); Cancer Research UK (14136)
Según 7 financiadores declarados.
Publicación
- Publicado
- 2011-11-23 · J Clin Endocrinol Metab · vol. 97 · número 2 · págs. 614–622
- Editorial
- Oxford University Press
- Citado
- 240 citas · más que el 100% de estudios similares · 15.6× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 38 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Vitamin D Research Studies · Bone health and osteoporosis research · Nutrition and Health Studies
- Palabras clave
- vitamin D3 supplementation, calcium supplementation, mortality, cancer incidence, cancer mortality, vascular death, older adults, fragility fractures, orthopedic patients, long-term follow-up, RECORD trial, medication adherence, fracture prevention, osteoporosis prevention, vitamin D receptor antagonists, parathyroid hormone, osteocalcin, bone turnover markers, bone mineral density
- MeSH
- humans, neoplasms, vascular diseases, calcium, cholecalciferol, drug combinations, placebos, mortality, cause of death, follow-up studies, time factors, dietary supplements, aged, aged, 80 and over, female, male, osteoporotic fractures
16 autores
- Alison Avenell🇬🇧 · autor de correspondenciaUniversity of Aberdeen
- Graeme MacLennan🇬🇧University of Aberdeen
- David J. Jenkinson🇬🇧University of Aberdeen
- Gladys C. McPherson🇬🇧University of Aberdeen
- Alison M. McDonald🇬🇧University of Aberdeen
- Puspa Raj Pant🇬🇧University of Aberdeen
- ADRIAN M. GRANT🇬🇧University of Aberdeen
- Marion Campbell🇬🇧University of Aberdeen
- Frazer H. Anderson
- Cyrus C. Cooper🇬🇧University of Oxford; MRC Lifecourse Epidemiology Unit; University of Southampton; Medical Research Council
- Roger M. Francis🇬🇧Newcastle University
- William John Gillespie🇬🇧University of Hull; Hull York Medical School
- C. M. Robinson🇬🇧Edinburgh Royal Infirmary
- David John Torgerson🇬🇧University of York
- William Angus Wallace🇬🇧University of Nottingham
- the RECORD Trial Group
Resumen
El texto original del estudio, en el idioma en que se publicó.
Context
Vitamin D or calcium supplementation may have effects on vascular disease and cancer.
Objective
Our objective was to investigate whether vitamin D or calcium supplementation affects mortality, vascular disease, and cancer in older people.
Design and setting
The study included long-term follow-up of participants in a two by two factorial, randomized controlled trial from 21 orthopedic centers in the United Kingdom.
Participants
Participants were 5292 people (85% women) aged at least 70 yr with previous low-trauma fracture.
Interventions
Participants were randomly allocated to daily vitamin D(3) (800 IU), calcium (1000 mg), both, or placebo for 24-62 months, with a follow-up of 3 yr after intervention.
Main outcome measures
All-cause mortality, vascular disease mortality, cancer mortality, and cancer incidence were evaluated.
Results
In intention-to-treat analyses, mortality [hazard ratio (HR) = 0.93; 95% confidence interval (CI) = 0.85-1.02], vascular disease mortality (HR = 0.91; 95% CI = 0.79-1.05), cancer mortality (HR = 0.85; 95% CI = 0.68-1.06), and cancer incidence (HR = 1.07; 95% CI = 0.92-1.25) did not differ significantly between participants allocated vitamin D and those not. All-cause mortality (HR = 1.03; 95% CI = 0.94-1.13), vascular disease mortality (HR = 1.07; 95% CI = 0.92-1.24), cancer mortality (HR = 1.13; 95% CI = 0.91-1.40), and cancer incidence (HR = 1.06; 95% CI = 0.91-1.23) also did not differ significantly between participants allocated calcium and those not. In a post hoc statistical analysis adjusting for compliance, thus with fewer participants, trends for reduced mortality with vitamin D and increased mortality with calcium were accentuated, although all results remain nonsignificant.
Conclusions
Daily vitamin D or calcium supplementation did not affect mortality, vascular disease, cancer mortality, or cancer incidence.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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