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Vitamin D and Omega-3 Trial: Ancillary Study (VITAL-Echo) on the Impact of Vitamin D Supplementation on Cardiac Structure and Function

50 Years
Open (Enrolling by invite only)
Cardiovascular Disease

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Trial Information

Vitamin D and Omega-3 Trial: Ancillary Study (VITAL-Echo) on the Impact of Vitamin D Supplementation on Cardiac Structure and Function

Recognition of the biological effects of vitamin D on cardiovascular function has been
growing. The main objective of the parent trial (VITAL) is to evaluate the effects of
vitamin D on cardiac events but is focused on atherothrombotic events and does not
specifically address vitamin D effects on LV mass. In ambulatory individuals, LV mass is a
key cardiac structural feature and increases in LV mass are frequently accompanied by
diastolic dysfunction. This study leverages the existing infrastructure of the parent VITAL
trial to perform cardiac imaging studies on a subset of subjects who will be randomized to
vitamin D3 (n=500) or placebo (n=500). Echocardiography is a noninvasive, widely accessible
tool to evaluate cardiac structure and function. Cardiac echo imaging visits will take place
at baseline (pre-randomization), and then after 2 years, at the Massachusetts General
Hospital (MGH). The acronym VITAL-Echo reflects the link to the parent VITAL trial and an
ancillary investigation of vitamin D versus placebo on LV mass and function as measured by
echocardiography. The effect of fish oil supplementation on these parameters will be
evaluated as a secondary endpoint, thereby taking advantage of the factorial design of the
parent trial.

Inclusion Criteria

Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to
participate in this ancillary study:


- 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)


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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Change in left ventricular (LV) mass

Outcome Description:

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

Outcome Time Frame:

Baseline and 2 years

Safety Issue:


Principal Investigator

Ravi I Thadhani, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

July 2010

Completion Date:

June 2016

Related Keywords:

  • Cardiovascular Disease
  • Vitamin D3
  • Left ventricular mass
  • Echocardiography
  • Left ventricular systolic and diastolic function
  • Cardiovascular Diseases



Massachusetts General HospitalBoston, Massachusetts  02114-2617