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In summary, daily supplementation with high-dose vitamin D for 5 years among initially healthy adults in the United States did not reduce the incidence of cancer or major cardiovascular events. BUT there is a signal that after 2 years Cancer Mortality Improved. Jules
Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease
Abstract
Background
It is unclear whether supplementation with vitamin D reduces the risk of cancer or cardiovascular disease, and data from randomized trials are limited.
Methods
We conducted a nationwide, randomized, placebo-controlled trial, with a two-by-two factorial design, of vitamin D3 (cholecalciferol) at a dose of 2000 IU per day and marine n−3 (also called omega-3) fatty acids at a dose of 1 g per day for the prevention of cancer and cardiovascular disease among men 50 years of age or older and women 55 years of age or older in the United States. Primary end points were invasive cancer of any type and major cardiovascular events (a composite of myocardial infarction, stroke, or death from cardiovascular causes). Secondary end points included site-specific cancers, death from cancer, and additional cardiovascular events. This article reports the results of the comparison of vitamin D with placebo.
Results
A total of 25,871 participants, including 5106 black participants, underwent randomization. Supplementation with vitamin D was not associated with a lower risk of either of the primary end points. During a median follow-up of 5.3 years, cancer was diagnosed in 1617 participants (793 in the vitamin D group and 824 in the placebo group; hazard ratio, 0.96; 95% confidence interval [CI], 0.88 to 1.06; P=0.47). A major cardiovascular event occurred in 805 participants (396 in the vitamin D group and 409 in the placebo group; hazard ratio, 0.97; 95% CI, 0.85 to 1.12; P=0.69). In the analyses of secondary end points, the hazard ratios were as follows: for death from cancer (341 deaths), 0.83 (95% CI, 0.67 to 1.02); for breast cancer, 1.02 (95% CI, 0.79 to 1.31); for prostate cancer, 0.88 (95% CI, 0.72 to 1.07); for colorectal cancer, 1.09 (95% CI, 0.73 to 1.62); for the expanded composite end point of major cardiovascular events plus coronary revascularization, 0.96 (95% CI, 0.86 to 1.08); for myocardial infarction, 0.96 (95% CI, 0.78 to 1.19); for stroke, 0.95 (95% CI, 0.76 to 1.20); and for death from cardiovascular causes, 1.11 (95% CI, 0.88 to 1.40). In the analysis of death from any cause (978 deaths), the hazard ratio was 0.99 (95% CI, 0.87 to 1.12). No excess risks of hypercalcemia or other adverse events were identified.
Conclusions
Supplementation with vitamin D did not result in a lower incidence of invasive cancer or cardiovascular events than placebo. (Funded by the National Institutes of Health and others; VITAL ClinicalTrials.gov number, NCT01169259.)
Discussion
In this large primary-prevention trial, supplementation with vitamin D3 (at a dose of 2000 IU per day) did not lead to a significantly lower incidence of invasive cancer of any type or a composite of major cardiovascular events (myocardial infarction, stroke, and death from cardiovascular causes) than placebo. The intervention also did not lead to a lower incidence of total deaths from cancer or a lower incidence of breast, prostate, or colorectal cancer than placebo.
Effects did not vary according to baseline serum 25-hydroxyvitamin D levels. The use of vitamin D did not lead to a significant difference in any of the secondary cardiovascular end points or in the rate of death from any cause in the overall cohort or in subgroups.
In analyses excluding early follow-up data, there was also no significant between-group difference in the incidence of invasive cancer of any type or major cardiovascular events. A post hoc analysis of the rate of death from cancer suggested a possible benefit with respect to the rate of total deaths from cancer after exclusion of early follow-up data, based on an unadjusted 95% confidence interval that does not include 1.
Cancer
The primary end point of invasive cancer of any type developed in 1617 participants, with similar event rates in the vitamin D group and the placebo group (793 and 824 participants with cancer, respectively; hazard ratio, 0.96; 95% confidence interval [CI], 0.88 to 1.06; P=0.47) (Table 2). No significant differences between the two groups were observed with regard to the incidence of breast, prostate, or colorectal cancer. During follow-up, 341 participants died from cancer, with 154 such deaths in the vitamin D group and 187 in the placebo group (hazard ratio, 0.83; 95% CI, 0.67 to 1.02).
The cumulative incidence of invasive cancer of any type (Figure 2A and Table 2) and death from cancer (Table 2, and Figure S2D in the Supplementary Appendix) did not differ significantly between the two groups. No significant differences between the two groups were observed with regard to preplanned analyses of the primary end point of cancer, excluding the first 1 and 2 years of follow-up. However, the test for proportionality over time was significant for the rate of death from cancer. In both an analysis that excluded 1 year of follow-up and an analysis that excluded 2 years of follow-up, neither of which was specified in the protocol, the rate of death from cancer was significantly lower with vitamin D than with placebo (hazard ratio, 0.79 [95% CI, 0.63 to 0.99], and hazard ratio, 0.75 [95% CI, 0.59 to 0.96], respectively). In analyses restricted to 153 deaths from cancer in patients with medical records or other adjudication of the cause of death beyond the NDI coding, the hazard ratios were 0.72 (95% CI, 0.52 to 1.00) over the total follow-up period and 0.63 (95% CI, 0.43 to 0.92) after the first 2 years were excluded. Preliminary analyses of cancer stage at diagnosis showed slightly fewer advanced cancers, metastatic cancers, or both among patients assigned to vitamin D than among those assigned to placebo, but differences were not significant (data not shown). The cumulative incidence rates of site-specific cancers and of death from cancer (prespecified secondary end points) are shown in Figure S2 in the Supplementary Appendix.
Results of prespecified subgroup analyses are presented in Table 3. The findings suggest that BMI may have modified the effect of vitamin D on cancer.
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