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

Phase 3

• Conditions: Aging
• Interventions: Dietary Supplement: Vitamin D3 (cholecalciferol); Drug: fish oil

• Registration Number: NCT04386577
• Lead Sponsor: Augusta University

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.

Study Timeline

• Study Start: 2016-08-19
• Study First Submitted: 2017-08-15
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-08
• Last Update Submitted: 2020-05-08
• Study First Posted: 2020-05-13
• Last Update Posted: 2020-05-13
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1054

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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Vitamin D + fish oil	Vitamin D3 (cholecalciferol)	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).
Vitamin D + fish oil placebo	Vitamin D3 (cholecalciferol)	Dietary supplement: Vitamin D3 (cholecalciferol), 2000 IU per day. Dietary supplement: Fish oil placebo
Vitamin D placebo + fish oil placebo	Vitamin D3 (cholecalciferol)	Dietary supplement: Vitamin D3 placebo Dietary supplement: Fish oil placebo
Vitamin D + fish oil	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).
Vitamin D placebo + fish oil	fish oil	Drug: Omega-3 fatty acids (fish oil), Omacor, 1 capsule per day. Dietary supplement: Vitamin D3 placebo
Vitamin D placebo + fish oil placebo	fish oil	Dietary supplement: Vitamin D3 placebo Dietary supplement: Fish oil placebo

Primary Outcome Measures

Name	Time	Method
Changes in telomere length	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 Outcome Measures

Name	Time	Method
Changes in Inflammation markers	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.

Trial Locations

Locations (1)

Georgia Prevention Institute; 🇺🇸 Augusta, Georgia, United States