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Long-Term Follow-Up for Mortality and Cancer in a Randomized Placebo-Controlled Trial of Vitamin D-3 and/or Calcium (RECORD Trial)

Lookup NU author(s): Emeritus Professor Roger Francis


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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. (J Clin Endocrinol Metab 97: 614-622, 2012)

Publication metadata

Author(s): 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 Grp

Publication type: Article

Publication status: Published

Journal: Journal of Clinical Endocrinology and Metabolism

Year: 2012

Volume: 97

Issue: 2

Pages: 614-622

Print publication date: 23/11/2011

ISSN (print): 0021-972X

ISSN (electronic): 1945-7197

Publisher: The Endocrine Society


DOI: 10.1210/jc.2011-1309


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Funder referenceFunder name
Shire Pharmaceuticals Group plc
Chief Scientist Office of the Scottish Government Health Directorates
G9706483United Kingdom Medical Research Council