Overview

This trial is active, not recruiting.

Condition cardiovascular disease
Treatments vitamin d3 + fish oil/fish oil placebo, vitamin d3 placebo + fish oil/fish oil placebo
Sponsor Massachusetts General Hospital
Collaborator Brigham and Women's Hospital
Start date July 2010
End date October 2017
Trial size 1000 participants
Trial identifier NCT01630213, 2009P-001217

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Vitamin D3 2000 IU/day and fish oil (840 omega 3-fatty acids; Omacor)(or fish oil placebo)/day
vitamin d3 + fish oil/fish oil placebo Cholecalciferol
Vitamin D3 2000 IU/day and fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo per day
(Placebo Comparator)
Vitamin D3 placebo + fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo
vitamin d3 placebo + fish oil/fish oil placebo Vitamin D3 placebo
Vitamin D3 placebo/day + fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo/day

Primary Outcomes

Measure
Change in left ventricular (LV) mass
time frame: Baseline and 2 years

Secondary Outcomes

Measure
Change in LV systolic/diastolic function
time frame: Baseline and 2 years
Change in LV mass
time frame: Baseline and 2 years
Change in LV systolic/diastolic function
time frame: Baseline and 2 years

Eligibility Criteria

Male or female participants at least 50 years old.

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.

Additional Information

Official title Vitamin D and Omega-3 Trial: Ancillary Study (VITAL-Echo) on the Impact of Vitamin D Supplementation on Cardiac Structure and Function
Principal investigator Ravi I Thadhani, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.