Clinical trial NCT01630213: Impact of Vitamin D Supplementation on Cardiac Structure and Function
Official title: Vitamin D and Omega-3 Trial: Ancillary Study (VITAL-Echo) on the Impact of Vitamin D Supplementation on Cardiac Structure and Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Vitamin D3
Left ventricular mass
Echocardiography
Left ventricular systolic and diastolic function
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2012-06-28
Enrollment: 1025
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Change in left ventricular (LV) mass
timeFrame: Baseline and 2 years
Secondary outcomes:
measure: Change in LV systolic/diastolic function
timeFrame: Baseline and 2 years
measure: Change in LV mass
timeFrame: Baseline and 2 years
measure: Change in LV systolic/diastolic function
timeFrame: Baseline and 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ravi I Thadhani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Thomas J Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Michael H Picard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.