Clinical trial NCT04386577: Effects of Vitamin D and Omega-3 Supplementation on Telomeres in VITAL
Official title: Effects of Vitamin D and Omega-3 Supplementation on Telomeres in VITAL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Aging
Keywords: vitamin D, omega-3 fatty acid, telomere length, inflammation
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-05-13
Enrollment: 1054
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: VITAL is a 2 x 2 factorial randomized, double-blind, placebo-controlled trial.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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:

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Exclusion Criteria: None

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Primary outcomes:
measure: Changes in telomere length
timeFrame: 4 years
Secondary outcomes:
measure: Changes in Inflammation markers
timeFrame: 4 years
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Prevention Institute
state: Georgia
Study officials:
affiliation: Augusta University
name: Yanbin Dong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: