Long-term follow-up for mortality and cancer in a randomized placebo-controlled trial of vitamin D3 and/or calcium (RECORD trial)

Alison Avenell, Graeme S. Maclennan, David J. Jenkinson, Gladys C. McPherson, Alison M. McDonald, Puspa R. Pant, Adrian M. Grant, Marion K. Campbell, Frazer H. Anderson, Cyrus Cooper, Roger M. Francis, William J. Gillespie, C. Michael Robinson, David J. Torgerson, W Angus. Wallace, the RECORD Trial Group

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Abstract

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.
Original languageEnglish
Pages (from-to)614-622
Number of pages9
JournalJournal of Clinical Endocrinology and Metabolism
Volume97
Issue number2
Early online date23 Nov 2011
DOIs
Publication statusPublished - 1 Feb 2012

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Cholecalciferol
Hazards
Randomized Controlled Trials
Placebos
Calcium
Vitamin D
Mortality
Vascular Diseases
Neoplasms
Confidence Intervals
Incidence
Orthopedics
Statistical methods
Intention to Treat Analysis
Compliance

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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 journalArticle

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 & the RECORD Trial Group 2012, 'Long-term follow-up for mortality and cancer in a randomized placebo-controlled trial of vitamin D3 and/or calcium (RECORD trial)', Journal of Clinical Endocrinology and Metabolism, vol. 97, no. 2, pp. 614-622. https://doi.org/10.1210/jc.2011-1309
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. / Long-term follow-up for mortality and cancer in a randomized placebo-controlled trial of vitamin D3 and/or calcium (RECORD trial). In: Journal of Clinical Endocrinology and Metabolism. 2012 ; Vol. 97, No. 2. pp. 614-622.
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abstract = "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.",
author = "Alison Avenell and Maclennan, {Graeme S.} and Jenkinson, {David J.} and McPherson, {Gladys C.} and McDonald, {Alison M.} and Pant, {Puspa R.} and Grant, {Adrian M.} and Campbell, {Marion K.} and Anderson, {Frazer H.} and Cyrus Cooper and Francis, {Roger M.} and Gillespie, {William J.} and Robinson, {C. Michael} and Torgerson, {David J.} and Wallace, {W Angus.} and {the RECORD Trial Group}",
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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

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 -