Impact of Vitamin D Supplementation on Cardiac Structure and Function
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/17/2018 |
| Start Date: | July 2010 |
| End Date: | December 2020 |
Vitamin D and Omega-3 Trial: Ancillary Study (VITAL-Echo) on the Impact of Vitamin D Supplementation on Cardiac Structure and Function
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.
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.
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.
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.
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.
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