VITAL

Clinical Trial Details

The VITamin D and OmegA-3 TriaL (VITAL): Principal Results for Vitamin D and Omega-3 Fatty Acid Supplementation in the Primary Prevention of Cardiovascular Disease and Cancer

The goal of VITAL was to investigate whether dietary vitamin D3 or omega-3 fatty acids reduced the risk for cancer, heart disease and stroke for people who were CVD- and cancer-free at the beginning of this study.

Key Findings

Major CVD events and total invasive cancer not significantly reduced by Omega-3 or vitamin D3. Omega-3 significantly reduced total MI, especially in African Americans and those with lower baseline fish intake.

Principal Investigator JoAnn Manson on VITAL

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JoAnn E. Manson, MD, DrPH, principal investigator, summarizes the results of the VITAL trial, which she presented during Scientific Sessions 2018 in Chicago.

VITAL - Commentary

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Don Lloyd-Jones, MD, ScM, vice chair of the program committee for Scientific Sessions 2018, comments on the results of the VITAL trial which was presented at the meeting in Chicago this year.

Purpose: To study the primary prevention role daily supplements of vitamin D3 or omega-3 fatty acids in reducing the risk of developing cancer, heart disease, and stroke in people with no history of cancer, heart disease or stroke.

Trial Design: 25,871 U.S. adults (men ≥50; women ≥55); median treatment 5.3 years. Double-blinded, placebo-controlled, randomized, 2x2 factorial: (1) vitamin D3 (cholecalciferol; 2000 IU daily) and marine omega-3 fatty acids (Omacor® fish oil, (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]], 1 g daily); (2) vitamin D and omega-3 placebo; (3) vitamin D placebo and omega-3 fatty acids; (4) both placebo.

Primary Endpoints: (a) MACE (composite MI, stroke, CVD mortality); (b) total invasive cancer.

VITAL Trial Data
  Vit D3 placebo O3FA placebo
MACE composite 396 events 409 events 386 events 419 events
HR=0.97 8% reduction (HR-0.92); p=0.24
Total Invasive Cancer 793 events 824 events 820 events 797 events
HR=0.96 No reduction (HR=1.03)
TOTAL MI 169 events 176 events 145 events 200 events
HR=0.96 28% reduction (HR=0.72, p=0.003)
MI in African Americans     9 events 39 events
  77% reduction, (HR=.23, interaction p=0.001)

Results: Major CVD events and total invasive cancer were not significantly reduced by Omega-3 or vitamin D3. Omega-3 significantly reduced total MI, especially in African Americans and those with lower fish intake.

Detailed Results

Omega 3

  1. Primary Endpoint 1:
    Major CVD events (composite endpoint of MI, stroke, and CVD mortality):
    • Omega-3: 386 events; placebo: 419 events; HR 0.92; p=0.24
    • Baseline fish consumption:
      <1.5 servings/week HR=0.81
      ≥ 1.5 servings/week HR=1.08
      interaction p=0.045
  2. Primary Endpoint 2:
    Total invasive cancer:
    • Omega-3: 820 events; placebo: 797 events; HR=1.03
       
  3. Secondary endpoints:
    • Total MI:
      • Omega-3: 145 events; placebo: 200 events; HR=0.72; p=0.003; 28% reduction
      • Fish consumption:
        <1.5 servings/week HR=0.60
        ≥ 1.5 servings/week HR=0.94
        interaction p=0.048
      • Subgroups
        • African Americans: Omega-3: 9 events; placebo: 39 events; HR=0.23
        • Non-Hispanic White: Omega-3: 126 events; placebo: 135 events; HR=0.93
        • Other: Omega-3: 8 events; placebo: 16 events; HR=0.54

        Interaction p=0.001
      • Total Cancer Mortality:
        • Omega-3: 168 events; placebo: 173 events; HR=0.97
        All-cause mortality:
         
      • Omega-3: 493 events; placebo: 485 events; HR=1.02

Vitamin D

  1. Primary Endpoint 1:
    Major CVD events (composite endpoint of MI, stroke, and CVD mortality):
    • Vitamin D: 396 events; placebo: 409 events; HR=0.97
       
  2. Primary Endpoint 2:
    Total invasive cancer: Vitamin D: 793 events; placebo 824 events; HR=0.96
     
  3. Secondary endpoints:
    • Total MI: Vitamin D: 169 events; placebo: 176 events; HR=0.96
    • Total cancer mortality: Vitamin D: 154 events; placebo: 187 events; HR=0.83; p=0.024
    • All-cause mortality: Vitamin D: 485 events; placebo: 493 events; HR=0.99

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Background

Trial Design — A phase 3, interventional, placebo-controlled, triple masked, randomized clinical trial comparing vitamin D (vitamin D3 [cholecalciferol] 2000 IU per day) and marine omega-3 fatty acid (465 mg eicosapentaenoic acid [EPA] + 375 mg docosahexaenoic acid [DHA]) supplements. Median follow-up: 5.3 years.

Participants were assigned one of four groups:

  1. daily vitamin D and omega-3;
  2. daily vitamin D and omega-3 placebo;
  3. daily vitamin D placebo and omega-3;
  4. daily vitamin D placebo and omega-3 placebo.

Trial Population — 25,871 participants (men ≥50 and women ≥55)

Primary Endpoints

  • major CVD events (composite endpoint of MI, stroke, and CVD mortality)
  • total invasive cancer

Secondary Endpoints

  • Composite of MACE + coronary revascularization (CABG or PCI)
  • individual components of composite CVD endpoints
  • site-specific cancers and total cancer mortality
  • all-cause and cause-specific mortality

Sponsor— Brigham and Women's Hospital

References

Key Words
AHA Scientific Sessions, AHA2018, vitamin D3, omega-3 fatty acids, fish oil, cardiovascular disease, cancer, primary prevention, ergocalciferols, cholecalciferol

Related Clinical Topics
nutrition, metabolism, stroke, cardiovascular disease, cancer, prevention