NCT01630213

Brief Summary

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 20,000 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 (VITAL-Echo) is being conducted among participants in VITAL and will examine whether vitamin D compared to placebo: (1) reduces left ventricular (LV) mass in elderly individuals as measured with 2-dimensional echocardiography and (2) improves LV systolic and diastolic function as measured with tissue Doppler echocardiography.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,025

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2016

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

5.8 years

First QC Date

June 25, 2012

Last Update Submit

April 5, 2022

Conditions

Cardiovascular Disease

Keywords

Vitamin D3Left ventricular massEchocardiographyLeft ventricular systolic and diastolic function

Outcome Measures

Primary Outcomes (1)

  • Change in left ventricular (LV) mass

    Primary aim is to examine whether vitamin D supplementation reduces LV mass in elderly individuals, using 2-dimensional echocardiography.

    Baseline and 2 years

Secondary Outcomes (3)

  • Change in LV systolic/diastolic function

    Baseline and 2 years

  • Change in LV mass

    Baseline and 2 years

  • Change in LV systolic/diastolic function

    Baseline and 2 years

Study Arms (2)

Vitamin D3 + fish oil/placebo

ACTIVE COMPARATOR

Vitamin D3 2000 IU/day and fish oil (840 omega 3-fatty acids; Omacor)(or fish oil placebo)/day

Dietary Supplement: Vitamin D3 + fish oil/fish oil placebo

Vitamin D3 placebo + fish oil/placebo

PLACEBO COMPARATOR

Vitamin D3 placebo + fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo

Dietary Supplement: Vitamin D3 placebo + fish oil/fish oil placebo

Interventions

Vitamin D3 + fish oil/fish oil placeboDIETARY_SUPPLEMENT

Vitamin D3 2000 IU/day and fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo per day

Also known as: Cholecalciferol, Omacor
Vitamin D3 + fish oil/placebo
Vitamin D3 placebo + fish oil/fish oil placeboDIETARY_SUPPLEMENT

Vitamin D3 placebo/day + fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo/day

Also known as: Vitamin D3 placebo, Omacor
Vitamin D3 placebo + fish oil/placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willingness to participate in ancillary study of VITAL to undergo cardiac echocardiography (baseline and at 3 years) and sign informed consent to participate in the ancillary study
  • Live in the greater Boston area (within 60 miles of MGH)

You may not qualify if:

  • Have a pacemaker, prosthetic valve(s), surgical wires or other devices that could alter the echocardiographic image findings.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Chandra A, Picard MH, Huang S, Gupta DK, Agusala K, Buring JE, Lee IM, Cook NR, Manson JE, Thadhani RI, Wang TJ. Impact of Vitamin D3 Versus Placebo on Cardiac Structure and Function: A Randomized Clinical Trial. J Am Heart Assoc. 2022 Nov;11(21):e025008. doi: 10.1161/JAHA.121.025008. Epub 2022 Oct 26.

    PMID: 36285795DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

CholecalciferolOmacor

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Ravi I Thadhani, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Thomas J Wang, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

  • Michael H Picard, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Nephrology; Director of Clinical Research in Nephrology

Study Record Dates

First Submitted

June 25, 2012

First Posted

June 28, 2012

Study Start

July 1, 2010

Primary Completion

April 11, 2016

Study Completion

June 30, 2021

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)