Cardiovascular Disease
Conditions
Keywords
Vitamin D3, Left ventricular mass, Echocardiography, Left ventricular systolic and diastolic function
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTVitamin D3 + fish oil/fish oil placebo
Vitamin D3 2000 IU/day and fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo per day
DIETARY_SUPPLEMENTVitamin D3 placebo + fish oil/fish oil placebo
Vitamin D3 placebo/day + fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo/day
Sponsors
Brigham and Women's Hospital
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study: Inclusion: * 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) Exclusion: * Have a pacemaker, prosthetic valve(s), surgical wires or other devices that could alter the echocardiographic image findings.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in left ventricular (LV) mass | Baseline and 2 years | Primary aim is to examine whether vitamin D supplementation reduces LV mass in elderly individuals, using 2-dimensional echocardiography. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in LV systolic/diastolic function | Baseline and 2 years | LV systolic and diastolic function using tissue Doppler echocardiography (2 D Echo will be used to measure ejection fraction in systole; E wave, E' E deceleration time, pulmonary vein inflow patterns in diastole; tissue doppler will measure S' in systole and E' in diastole; Speckle tracking will measure global longitudinal strain, LV torsion in systole and oeak LV untwisting rate in diastole). |
| Change in LV mass | Baseline and 2 years | To examine whether vitamin D supplementation with/without fish oil supplementation reduces LV mass in elderly individuals, using 2-dimensional echocardiography. |
Countries
United States
Outcome results
None listed