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Impact of Vitamin D Supplementation on Cardiac Structure and Function

NCT01630213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1025

Last updated 2022-04-06

No results posted yet for this study

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.

Conditions

Interventions

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

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

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Ravi I Thadhani, MD, MPH · Massachusetts General Hospital

  • Thomas J Wang, MD · Vanderbilt University Medical Center

  • Michael H Picard, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-01
Primary Completion
2016-04-11
Completion
2021-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01630213 on ClinicalTrials.gov