NCT04386577 is a Phase 3 clinical trial of Vitamin D3 (cholecalciferol) in Aging, sponsored by Augusta University.

Who is sponsoring NCT04386577?

NCT04386577 is sponsored by Augusta University.

What drugs are being tested in NCT04386577?

Interventions in NCT04386577: Vitamin D3 (cholecalciferol), fish oil.

Is NCT04386577 still recruiting?

NCT04386577 is currently status unknown. Last updated 13 May 2020.

Last reviewed 2020-05-13 · How we verify

NCT04386577

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 3 Last updated 13 May 2020

What this trial tests

Phase 3 trial testing Vitamin D3 (cholecalciferol) in Aging in 1,054 participants. Status unknown.

Timeline

19 August 2016

Primary endpoint
30 April 2021

30 April 2021

Quick facts

Lead sponsor	Augusta University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	triple
Primary purpose	prevention
Enrollment	1,054
Start date	19 August 2016
Primary completion	30 April 2021
Estimated completion	30 April 2021
Sites	1 location across United States

Drugs / interventions tested

Vitamin D3 (cholecalciferol)
fish oil — full drug profile →

Conditions studied

Aging — all drugs for Aging →

Sponsor

Augusta University

Who can join

50 and older, any sex, with Aging. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Natural Compounds of Marine Origin as Inducers of Immunogenic Cell Death (ICD): Potential Role for Cancer Interception and Therapy.
Sansone C, Bruno A, Piscitelli C, Baci D, et al · · 2021 · cited 39× · PMID 33504012 · DOI 10.3390/cells10020231
Effects of Vitamin D<sub>3</sub> and Marine Omega-3 Fatty Acids Supplementation on Biomarkers of Systemic Inflammation: 4-Year Findings from the VITAL Randomized Trial.
Dong Y, Zhu H, Chen L, Huang Y, et al · · 2022 · cited 24× · PMID 36558465 · DOI 10.3390/nu14245307
Vitamin D<sub>3</sub> and marine ω-3 fatty acids supplementation and leukocyte telomere length: 4-year findings from the VITamin D and OmegA-3 TriaL (VITAL) randomized controlled trial.
Zhu H, Manson JE, Cook NR, Bekele BB, et al · · 2025 · cited 4× · PMID 40409468 · DOI 10.1016/j.ajcnut.2025.05.003
Repurposing effect of cardiovascular-metabolic drug to increase lifespan: a systematic review of animal studies and current clinical trial progress.
Barinda AJ, Hardi H, Louisa M, Khatimah NG, et al · · 2024 · cited 4× · PMID 38966557 · DOI 10.3389/fphar.2024.1373458

Verify or expand the search:

Other trials of Vitamin D3 (cholecalciferol)

Trials testing the same drug.

NCT04641195 — Vitamin D and Zinc Supplementation for Improving Treatment Outcomes Among COVID-19 Patients in India · Phase 3 · completed
NCT03313076 — Vitamin D and n-3 Polyunsaturated Fatty Acids (PUFAs) to Prevent Chronic Pain Following Major Thermal Burn Injury · Phase 2 · terminated
NCT03437421 — Myocardial Function and Vitamin D Supplementation in Diabetes. · NA · completed
NCT02305927 — Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health · Phase 3 · completed

Other recruiting trials for Aging

Currently open trials in the same condition.

NCT02831335 — Technical Development of Multi-Parametric Renocerebral MRI · recruiting
NCT07099053 — Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging · recruiting
NCT07504068 — Effects of Physical Exercise and a Nutritional Supplement on Body Composition, Metabolic Function, and Overall Health in · NA · recruiting
NCT07525453 — Effects of Three Different Exercise Programs on Dynamic Balance in Community-Dwelling Older Adults · NA · recruiting
NCT07500727 — Skeletal Muscle Aging and Responsiveness in Aged People With MS · NA · recruiting

Other Augusta University trials

Trials by the same sponsor.

NCT07341841 — Assessing Obesity Related Risk Factors in Adult Population: A Genetic and Behavioral Study · NA · enrolling by invitation
NCT07489144 — CO-creating Novel, Feasible, and Inclusive Research Methods · NA · active not recruiting
NCT06514014 — Transition From Donor Milk: a Feasibility Study · NA · recruiting
NCT06907992 — A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated C · not yet recruiting
NCT06058169 — Effects of Home Base Whole-body Vibration in Osteoarthritis. (VIBE-Rx2) · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04386577 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Augusta University
Last refreshed: 13 May 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04386577.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing