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

Avenell, Alison; MacLennan, Graeme; Jenkinson, D; McPherson, Gladys; McDonald, Alison; Pant, Puspa Raj; Grant, Adrian; Campbell, Marion K; Anderson, Fiona; Cooper, Cyrus; Francis, Roger M.; Gillespie, W. J.; Robinson, C. M.; Torgerson, David; Wallace, W. Angus

doi:10.1210/jc.2011-1309

Cited by 222 publications

(177 citation statements)

References 41 publications

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“…Few prospective intervention studies with sufficient statistical power have addressed this question. Both the Women's Health Initiative study, which followed .36,000 women, and the RECORD trial, which studied .5,000 patients, failed to show cardiovascular benefit (40,41), but metanalysis suggests the formulation of vitamin D may be important (27,28).…”

Section: Resultsmentioning

confidence: 99%

Serum 25-Hydroxyvitamin D: A Predictor of Macrovascular and Microvascular Complications in Patients With Type 2 Diabetes

et al. 2014

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OBJECTIVEPeople with diabetes frequently develop vascular disease. We investigated the relationship between blood 25-hydroxyvitamin D (25OH-D) concentration and vascular disease risk in type 2 diabetes. RESEARCH DESIGN AND METHODSThe relationships between blood 25OH-D concentration at baseline and the incidence of macrovascular (including myocardial infarction and stroke) and microvascular (retinopathy, nephropathy, neuropathy, and amputation) disease were analyzed with Cox proportional hazards models and logistic regression in an observational study of patients in the 5-year Fenofibrate Intervention and Event Lowering in Diabetes trial. RESULTSA total of 50% of the patients had low vitamin D concentrations, as indicated by median blood 25OH-D concentration of 49 nmol/L. These patients with a blood 25OH-D concentration <50 nmol/L had a higher cumulative incidence of macrovascular and microvascular events than those with levels ‡50 nmol/L. Multivariate analysis, stratified by treatment and adjusted for relevant confounders, identified blood 25OH-D concentration as an independent predictor of macrovascular events. A 50 nmol/L difference in blood 25OH-D concentration was associated with a 23% (P = 0.007) change in risk of macrovascular complications during the study, and further adjustments for seasonality, hs-CRP, and physical activity level had little impact. The unadjusted risk of microvascular complications was 18% (P = 0.006) higher during the study, though the excess risk declined to 11-14% and lost significance with adjustment for HbA 1c , seasonality, or physical activity. CONCLUSIONSLow blood 25OH-D concentrations are associated with an increased risk of macrovascular and microvascular disease events in type 2 diabetes. However, a causal link remains to be demonstrated.Diabetes is among the leading causes of death and affects 347 million people worldwide. The World Health Organization expects a 50% increase in deaths from diabetes over the next 10 years, and by 2030, diabetes is projected to be the seventh leading cause of death (1). Most major complications involve large vessel (macrovascular) or small vessel (microvascular) disease.

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Section: Resultsmentioning

confidence: 99%

Serum 25-Hydroxyvitamin D: A Predictor of Macrovascular and Microvascular Complications in Patients With Type 2 Diabetes

et al. 2014

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“…This was however assessed in EPIC-Heidelberg, which showed that calcium supplements were used by less than 10% of subjects (42). Furthermore, results of a randomized controlled trial, investigating the risk of cancer death in over 5,000 subjects with previous fractures who were randomized to use calcium supplements, showed no association between calcium supplements use and cancer mortality (43). Nevertheless, the prediagnostic assessment and the lacking data on calcium supplements may have led, in combination with the self-reported design of the questionnaires, to attenuated risk estimates.…”

Section: Discussionmentioning

confidence: 99%

Prediagnostic Intake of Dairy Products and Dietary Calcium and Colorectal Cancer Survival—Results from the EPIC Cohort Study

Dik

Murphy

Siersema

et al. 2014

Cancer Epidemiology, Biomarkers &Amp; Prevention

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Background: We investigated whether prediagnostic reported intake of dairy products and dietary calcium is associated with colorectal cancer survival.Methods: Data from 3,859 subjects with colorectal cancer (42.1% male; mean age at diagnosis, 64.2 AE 8.1 years) in the European Investigation into Cancer and Nutrition cohort were analyzed. Intake of dairy products and dietary calcium was assessed at baseline (1992-2000) using validated, country-specific dietary questionnaires. Multivariable Cox regression models were used to calculate HR and corresponding 95% confidence intervals (CI) for colorectal cancer-specific death (n ¼ 1,028) and all-cause death (n ¼ 1,525) for different quartiles of intake.Results: The consumption of total dairy products was not statistically significantly associated with risk of colorectal cancer-specific death (adjusted HR Q4 vs. Q1, 1.17; 95% CI, 0.97-1.43) nor that of all-cause death (Q4 vs. Q1, 1.16; 95% CI, 0.98-1.36). Multivariable-adjusted HRs for colorectal cancer-specific death (Q4 vs. Q1) were 1.21 (95% CI, 0.99-1.48) for milk, 1.09 (95% CI, 0.88-1.34) for yoghurt, and 0.93 (95% CI, 0.76-1.14) for cheese. The intake of dietary calcium was not associated with the risk of colorectal cancer-specific death (adjusted HR Q4 vs. Q1, 1.01; 95% CI, 0.81-1.26) nor that of all-cause death (Q4 vs. Q1, 1.01; 95% CI, 0.84-1.21).Conclusions: The prediagnostic reported intake of dairy products and dietary calcium is not associated with disease-specific or all-cause risk of death in patients diagnosed with colorectal cancer.Impact: The impact of diet on cancer survival is largely unknown. This study shows that despite its inverse association with colorectal cancer risk, the prediagnostic intake of dairy and dietary calcium does not affect colorectal cancer survival. Cancer Epidemiol Biomarkers Prev; 23(9); 1813-23. Ó2014 AACR.

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“…Three randomized controlled trials of supplementation reported nonsignificantly lower overall cancer mortality with vitamin D supplementation (93)(94)(95) (Table 2), 1 of which also reported no effect on colon and respiratory cancer mortality (93). These trials were not powered for cancer mortality outcomes, however (96).…”

Section: Vitamin D Supplementationmentioning

confidence: 99%

Vitamin D and Cancer Risk and Mortality: State of the Science, Gaps, and Challenges

Mondul

Weinstein

Layne

et al. 2017

Epidemiologic Reviews

167

133

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There has been substantial enthusiasm recently regarding the potential role of vitamin D in the primary and secondary prevention of cancer. Laboratory studies demonstrate a range of anticarcinogenic effects for vitamin D compounds, but human studies have yielded little consistent evidence supporting a protective association. Higher circulating levels of vitamin D (i.e., 25-hydroxyvitamin D or 25(OH)D) appear to be associated with reduced risk of colorectal and bladder malignancies, but higher risk of prostate and possibly pancreatic cancers, with no clear association for most other organ sites examined. Despite there being no official institutional recommendations regarding the use of vitamin D supplements for cancer prevention, screenings for vitamin D deficiency and vitamin D supplement use have increased substantially over the past decade. These widespread practices demonstrate that population sociobehavioral changes are often adopted before scientifically well-informed policies and recommendations are available. This review critically examines the currently available epidemiologic literature regarding the associations between circulating 25(OH)D, vitamin D supplementation, and vitamin D-related genetic variation and cancer risk and mortality, with a particular emphasis on prospective studies. We identify several important gaps in our scientific knowledge that should be addressed in order to provide sufficient reproducible data to inform evidence-based recommendations related to optimal 25(OH)D concentrations (and any role for vitamin D supplementation) for the primary and secondary prevention of cancer. With few exceptions, such recommendations cannot be made at this time.

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Long-Term Follow-Up for Mortality and Cancer in a Randomized Placebo-Controlled Trial of Vitamin D₃and/or Calcium (RECORD Trial)

Abstract: Daily vitamin D or calcium supplementation did not affect mortality, vascular disease, cancer mortality, or cancer incidence.

Cited by 222 publications

References 41 publications

Serum 25-Hydroxyvitamin D: A Predictor of Macrovascular and Microvascular Complications in Patients With Type 2 Diabetes

Serum 25-Hydroxyvitamin D: A Predictor of Macrovascular and Microvascular Complications in Patients With Type 2 Diabetes

Prediagnostic Intake of Dairy Products and Dietary Calcium and Colorectal Cancer Survival—Results from the EPIC Cohort Study

Vitamin D and Cancer Risk and Mortality: State of the Science, Gaps, and Challenges

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Long-Term Follow-Up for Mortality and Cancer in a Randomized Placebo-Controlled Trial of Vitamin D3and/or Calcium (RECORD Trial)

Abstract: Daily vitamin D or calcium supplementation did not affect mortality, vascular disease, cancer mortality, or cancer incidence.

Cited by 222 publications

References 41 publications

Serum 25-Hydroxyvitamin D: A Predictor of Macrovascular and Microvascular Complications in Patients With Type 2 Diabetes

Serum 25-Hydroxyvitamin D: A Predictor of Macrovascular and Microvascular Complications in Patients With Type 2 Diabetes

Prediagnostic Intake of Dairy Products and Dietary Calcium and Colorectal Cancer Survival—Results from the EPIC Cohort Study

Vitamin D and Cancer Risk and Mortality: State of the Science, Gaps, and Challenges

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Long-Term Follow-Up for Mortality and Cancer in a Randomized Placebo-Controlled Trial of Vitamin D₃and/or Calcium (RECORD Trial)