Effects of Vitamin D and Omega-3 Supplementation on Telomeres in VITAL

Overview

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) was a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL-CTSC cohort and will examine whether vitamin D or fish oil supplementation has beneficial effects on cellular aging.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 30, 2021

Detailed Description

This project is an ancillary study based on the parental study "the VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259)" at the Harvard Clinical and Translational Science Centre (CTSC) and Brigham and Women's Hospital. Our research focuses on the separate and synergistic effects of vitamin D and omega -3 supplements on telomere length, a cellular aging marker, using de-identified samples from VITAL-CTSC cohort.

Aims: 1) To test the hypothesis that vitamin D supplementation decreases leukocyte telomere length attrition. The investigators will determine the effect of vitamin D supplementation on telomere length attrition over time (Baseline, Year 2, and Year 4); 2) To test the hypothesis that marine omega-3 fatty acid supplementation decreases LTL attrition. The investigators will determine the effect of marine omega-3 fatty acid supplementation on telomere length attrition over time (Baseline, Year 2, and Year 4); 3) To determine to what extent the effects of vitamin D or omega-3 supplementation on inflammatory cytokines and CVD risk factors are mediated by telomere length attrition over time; 4) To explore the synergistic effects vitamin D and omega-3 fatty acid supplementation.

Interventions

  • Dietary Supplement: Vitamin D3 (cholecalciferol)
    • Eligible participants were assigned by chance to one of four groups: (1) daily vitamin D3 and omega-3; (2) daily vitamin D3 and omega-3 placebo; (3) daily vitamin D placebo and omega-3; or (4) daily vitamin D placebo and omega-3 placebo. At baseline, year 2 and year 4 of the trial, a subcohort of 1,054 VITAL participants living within driving distance of Boston, Massachusetts received detailed in-clinic health assessments at the Clinical and Translational Science Center (CTSC) of Brigham and Women’s Hospital. During CTSC visits, participants have a clinical exam, including measurement of height, weight, other anthropometrics, blood pressure, and physical performance. They also provide fasting blood and urine samples, and undergo 2-hour oral glucose tolerance testing, lung function testing (spirometry), electrocardiograms, bone mineral density testing, 2D-echocardiography, and assessments of thinking and mood.
  • Drug: fish oil
    • Eligible participants were assigned by chance to one of four groups: (1) daily vitamin D3 and omega-3; (2) daily vitamin D3 and omega-3 placebo; (3) daily vitamin D placebo and omega-3; or (4) daily vitamin D placebo and omega-3 placebo. At baseline, year 2 and year 4 of the trial, a subcohort of 1,054 VITAL participants living within driving distance of Boston, Massachusetts received detailed in-clinic health assessments at the Clinical and Translational Science Center (CTSC) of Brigham and Women’s Hospital. During CTSC visits, participants have a clinical exam, including measurement of height, weight, other anthropometrics, blood pressure, and physical performance. They also provide fasting blood and urine samples, and undergo 2-hour oral glucose tolerance testing, lung function testing (spirometry), electrocardiograms, bone mineral density testing, 2D-echocardiography, and assessments of thinking and mood.

Arms, Groups and Cohorts

  • Active Comparator: Vitamin D + fish oil
    • Dietary supplement: Vitamin D3 (cholecalciferol), 2000 IU per day. Drug: Omega-3 fatty acids (fish oil), Omacor, 1 capsule per day. Each capsule contains 840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid (EPA) and 375 mg of docosahexaenoic acid (DHA).
  • Active Comparator: Vitamin D + fish oil placebo
    • Dietary supplement: Vitamin D3 (cholecalciferol), 2000 IU per day. Dietary supplement: Fish oil placebo
  • Active Comparator: Vitamin D placebo + fish oil
    • Drug: Omega-3 fatty acids (fish oil), Omacor, 1 capsule per day. Dietary supplement: Vitamin D3 placebo
  • Placebo Comparator: Vitamin D placebo + fish oil placebo
    • Dietary supplement: Vitamin D3 placebo Dietary supplement: Fish oil placebo

Clinical Trial Outcome Measures

Primary Measures

  • Changes in telomere length
    • Time Frame: 4 years
    • Leukocyte telomere length (LTL) will be measured using quantitative polymerase chain reaction method at the baseline, year 2 and year 4. we will examine the effect of randomization to vitamin D (primary Aim 1 and or fish oil (primary Aim 2) compared o placebo is different over time on changes in telomere length.

Secondary Measures

  • Changes in Inflammation markers
    • Time Frame: 4 years
    • We will examine the changes in plasma markers of inflammation (CRP, interleukin-6 (IL-6), interleukin-10 (IL-10), interleukin-12 (IL-12), tumor necrosis factor-alpha (TNF-a) in plasma samples collected at the baseline, year 2 and year 4. We will examine whether change in LTL is a mediator of change of inflammatory and cardiovascular disease (CVD) risk.

Participating in This Clinical Trial

Inclusion Criteria

The subcohort of 1,054 participants in VITAL (NCT 01169259) who are receiving detailed health assessments at a Clinical and Translation Science Center at Boston are eligible to participate in this ancillary study:

Exclusion Criteria

None

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Augusta University
  • Collaborator
    • National Heart, Lung, and Blood Institute (NHLBI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yanbin Dong, Regents Professor – Augusta University
  • Overall Official(s)
    • Yanbin Dong, MD, PhD, Principal Investigator, Augusta University

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