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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Ravi Thadhani, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01630213
First received: June 25, 2012
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Dietary Supplement: Vitamin D3 + fish oil/fish oil placebo
Dietary Supplement: Vitamin D3 placebo + fish oil/fish oil placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D and Omega-3 Trial: Ancillary Study (VITAL-Echo) on the Impact of Vitamin D Supplementation on Cardiac Structure and Function

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in left ventricular (LV) mass [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]
    Primary aim is to examine whether vitamin D supplementation reduces LV mass in elderly individuals, using 2-dimensional echocardiography.


Secondary Outcome Measures:
  • Change in LV systolic/diastolic function [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Effect of Vitamin D with/without fish-oil on LV systolic and diastolic function using tissue Doppler echocardiography (as above).


Enrollment: 1000
Study Start Date: July 2010
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Placebo Comparator: Vitamin D3 placebo + fish oil/placebo
Vitamin D3 placebo + fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo
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

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630213

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Brigham and Women's Hospital
Investigators
Principal Investigator: Ravi I Thadhani, MD, MPH Massachusetts General Hospital
Principal Investigator: Thomas Wang, MD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Ravi Thadhani, Chief, Division of Nephrology; Director of Clinical Research in Nephrology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01630213     History of Changes
Other Study ID Numbers: 2009P-001217
Study First Received: June 25, 2012
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Vitamin D3
Left ventricular mass
Echocardiography
Left ventricular systolic and diastolic function

Additional relevant MeSH terms:
Cardiovascular Diseases
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014