title: Long-term follow-up for mortality and cancer in a randomized placebo-controlled trial of vitamin D(3) and/or calcium (RECORD trial).
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  Participants were 5292 people (85% women) aged at least 70 yr with previous low-trauma fracture.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors: Health Services Research Unit, University of Aberdeen, Foresterhill, Aberdeen AB25 2ZD, UK. a.avenell@abdn.ac.uk
authors: Alison
authors: A
authors: Avenell
authors: Graeme S
authors: GS
authors: MacLennan
authors: David J
authors: DJ
authors: Jenkinson
authors: Gladys C
authors: GC
authors: McPherson
authors: Alison M
authors: AM
authors: McDonald
authors: Puspa R
authors: PR
authors: Pant
authors: Adrian M
authors: AM
authors: Grant
authors: Marion K
authors: MK
authors: Campbell
authors: Frazer H
authors: FH
authors: Anderson
authors: Cyrus
authors: C
authors: Cooper
authors: Roger M
authors: RM
authors: Francis
authors: William J
authors: WJ
authors: Gillespie
authors: C Michael
authors: CM
authors: Robinson
authors: David J
authors: DJ
authors: Torgerson
authors: W Angus
authors: WA
authors: Wallace
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002118:Calcium / Q000008:administration & dosage*; D002423:Cause of Death; D002762:Cholecalciferol / Q000008:administration & dosage*; D019587:Dietary Supplements; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009026:Mortality / Q000639:trends; D009369:Neoplasms / Q000453:epidemiology* / Q000401:mortality; D058866:Osteoporotic Fractures / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology / Q000401:mortality; D010919:Placebos; D013997:Time Factors; D014652:Vascular Diseases / Q000453:epidemiology / Q000401:mortality
chemical_list: D004338:Drug Combinations; D010919:Placebos; D002762:Cholecalciferol; D002118:Calcium