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  • VITAL (Vitamin D arm) Original

    • VITAL (Vitamin D arm)

    "Vitamin D, Omega-3 Trial (VITAL)". The New England Journal of Medicine. 2018. DOI:10.1056/NEJMoa1811403.

    ### Clinical Question
    Does supplementation with Vitamin D (2000 IU/day) reduce the risk of cancer or cardiovascular disease among older adults?

    ### Bottom Line
    Supplementation with Vitamin D did not result in a lower incidence of invasive cancer or cardiovascular events compared to a placebo.

    ### Major Points
    VITAL was a large-scale, randomized, placebo-controlled trial that tested the effects of daily Vitamin D (2000 IU) and Omega-3 fatty acids (1 g) on the primary prevention of cancer and cardiovascular disease in older adults. With a median 5.3 years follow-up, neither the incidence of invasive cancer nor major cardiovascular events was reduced by Vitamin D supplementation.

    ### Guidelines
    Current guidelines from the U.S. Preventive Services Task Force report insufficient data to evaluate the effectiveness of Vitamin D supplementation for cancer or cardiovascular disease prevention.

    ### Design
    - Nationwide, randomized, double-blind, placebo-controlled trial with two-by-two factorial design
    - N=25,871 men (aged ≥50) and women (aged ≥55)
    - Intervention: Vitamin D3 (cholecalciferol) 2000 IU/day
    - Comparators: Placebo
    - Primary endpoints: invasive cancer of any type, major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes)
    - Secondary endpoints: site-specific cancers, death from cancer, and additional cardiovascular events
    - Median follow-up: 5.3 years

    ### Population
    - Inclusion criteria: Men ≥50 years old and women ≥55 years old, no history of cancer (except nonmelanoma skin cancer) or cardiovascular disease at trial entry
    - Exclusion criteria: History of various serious conditions, including hypercalcemia and renal failure
    - Baseline characteristics: Mean age 67.1 years, 51% women, racially diverse (20% black participants)

    ### Interventions
    - Vitamin D3 (cholecalciferol) 2000 IU per day

    ### Outcomes
    - Primary outcomes: Invasive cancer (HR 0.96, 95% CI 0.88-1.06), major cardiovascular events (HR 0.97, 95% CI 0.85-1.12)
    - Secondary outcomes: No significant differences in site-specific cancers or cardiovascular events
    - Death from cancer: Non-significant reduction (HR 0.83, 95% CI 0.67-1.02)
    - Adverse events: Hypercalcemia, kidney stones, and gastrointestinal symptoms were not significantly different between the Vitamin D and placebo groups

    ### Criticisms
    - The lack of significant results may be due to the study design, including the duration of follow-up and the selected Vitamin D dose.
    - Subgroup analyses should be interpreted with caution, as they were not adjusted for multiple comparisons.

    ### Funding
    - Funded by the National Institutes of Health and others
    - Trial agents donated by Pharmavite (Vitamin D) and Pronova BioPharma/BASF (fish oil)

    ### Further Reading
    - VITAL research group's full list of members and supplementary material are available at NEJM.org.