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Impact of Vitamin D Supplementation on Cardiac Structure and Function (VITAL-Echo)

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ClinicalTrials.gov Identifier: NCT01630213
Recruitment Status : Active, not recruiting
First Posted : June 28, 2012
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Ravi Thadhani, Massachusetts General Hospital

June 25, 2012
June 28, 2012
March 22, 2018
July 2010
October 2020   (Final data collection date for primary outcome measure)
Change in left ventricular (LV) mass [ Time Frame: Baseline and 2 years ]
Primary aim is to examine whether vitamin D supplementation reduces LV mass in elderly individuals, using 2-dimensional echocardiography.
Same as current
Complete list of historical versions of study NCT01630213 on ClinicalTrials.gov Archive Site
  • Change in LV systolic/diastolic function [ Time Frame: 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 [ Time Frame: 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.
  • Change in LV systolic/diastolic function [ Time Frame: Baseline and 2 years ]
    Effect of Vitamin D with/without fish-oil on LV systolic and diastolic function using tissue Doppler echocardiography (as above).
Same as current
Not Provided
Not Provided
 
Impact of Vitamin D Supplementation on Cardiac Structure and Function
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cardiovascular Disease
  • Dietary Supplement: Vitamin 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
    Other Names:
    • Cholecalciferol
    • Omacor
  • Dietary Supplement: Vitamin 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
    Other Names:
    • Vitamin D3 placebo
    • Omacor
  • Active Comparator: Vitamin D3 + fish oil/placebo
    Vitamin D3 2000 IU/day and fish oil (840 omega 3-fatty acids; Omacor)(or fish oil placebo)/day
    Intervention: Dietary Supplement: Vitamin D3 + fish oil/fish oil placebo
  • Placebo Comparator: Vitamin D3 placebo + fish oil/placebo
    Vitamin D3 placebo + fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo
    Intervention: Dietary Supplement: Vitamin D3 placebo + fish oil/fish oil placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
Same as current
December 2020
October 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01630213
2009P-001217
Yes
Not Provided
Plan to Share IPD: No
Ravi Thadhani, Massachusetts General Hospital
Massachusetts General Hospital
Brigham and Women's Hospital
Principal Investigator: Ravi I Thadhani, MD, MPH Massachusetts General Hospital
Principal Investigator: Thomas J Wang, MD Vanderbilt University Medical Center
Principal Investigator: Michael H Picard, MD Massachusetts General Hospital
Massachusetts General Hospital
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP