Abstract
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 D3 (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.
| Original language | English |
|---|---|
| Pages (from-to) | 614-622 |
| Number of pages | 9 |
| Journal | Journal of Clinical Endocrinology and Metabolism |
| Volume | 97 |
| Issue number | 2 |
| Early online date | 23 Nov 2011 |
| DOIs | |
| Publication status | Published - 1 Feb 2012 |
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Long-term follow-up for mortality and cancer in a randomized placebo-controlled trial of vitamin D3 and/or calcium (RECORD trial). / Avenell, Alison; Maclennan, Graeme S.; Jenkinson, David J.; McPherson, Gladys C.; McDonald, Alison M.; Pant, Puspa R.; Grant, Adrian M.; Campbell, Marion K.; Anderson, Frazer H.; Cooper, Cyrus; Francis, Roger M.; Gillespie, William J.; Robinson, C. Michael; Torgerson, David J.; Wallace, W Angus.; the RECORD Trial Group.
In: Journal of Clinical Endocrinology and Metabolism, Vol. 97, No. 2, 01.02.2012, p. 614-622.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Long-term follow-up for mortality and cancer in a randomized placebo-controlled trial of vitamin D3 and/or calcium (RECORD trial)
AU - Avenell, Alison
AU - Maclennan, Graeme S.
AU - Jenkinson, David J.
AU - McPherson, Gladys C.
AU - McDonald, Alison M.
AU - Pant, Puspa R.
AU - Grant, Adrian M.
AU - Campbell, Marion K.
AU - Anderson, Frazer H.
AU - Cooper, Cyrus
AU - Francis, Roger M.
AU - Gillespie, William J.
AU - Robinson, C. Michael
AU - Torgerson, David J.
AU - Wallace, W Angus.
AU - the RECORD Trial Group
PY - 2012/2/1
Y1 - 2012/2/1
N2 - 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 D3 (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.
AB - 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 D3 (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.
U2 - 10.1210/jc.2011-1309
DO - 10.1210/jc.2011-1309
M3 - Article
C2 - 22112804
VL - 97
SP - 614
EP - 622
JO - Journal of Clinical Endocrinology and Metabolism
JF - Journal of Clinical Endocrinology and Metabolism
SN - 0021-972X
IS - 2
ER -