Cardiovascular DiseaseVITAL-EchoNCT01630213
Impact of Vitamin D Supplementation on Cardiac Structure and Function
A study of Cardiovascular Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,025 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2010to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Have a pacemaker, prosthetic valve(s), surgical wires or other devices that could alter the echocardiographic image findings.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Vitamin D3 + fish oil/fish oil placebo, Vitamin D3 placebo + fish oil/fish oil placebo
- Keywords
- Vitamin D3, Left ventricular mass, Echocardiography, Left ventricular systolic and diastolic function
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 + fish oil/fish oil placeboDietary supplement
Also called Cholecalciferol, Omacor
Vitamin D3 2000 IU/day and fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo per day
Vitamin D3 placebo + fish oil/fish oil placeboDietary supplement
Also called Vitamin D3 placebo, Omacor
Vitamin D3 placebo/day + fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo/day
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 + fish oil/placebo | Active comparator | Vitamin D3 2000 IU/day and fish oil (840 omega 3-fatty acids; Omacor)(or fish oil placebo)/day Receives: Dietary Supplement: Vitamin D3 + fish oil/fish oil placebo |
| Vitamin D3 placebo + fish oil/placebo | Placebo comparator | Vitamin D3 placebo + fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo Receives: Dietary Supplement: Vitamin D3 placebo + fish oil/fish oil placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular (LV) mass
Primary aim is to examine whether vitamin D supplementation reduces LV mass in elderly individuals, using 2-dimensional echocardiography.
Measured: Baseline and 2 years
Secondary outcomes (3)
Change in LV systolic/diastolic function
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).
Measured: Baseline and 2 years
Change in LV mass
To examine whether vitamin D supplementation with/without fish oil supplementation reduces LV mass in elderly individuals, using 2-dimensional echocardiography.
Measured: Baseline and 2 years
Change in LV systolic/diastolic function
Effect of Vitamin D with/without fish-oil on LV systolic and diastolic function using tissue Doppler echocardiography (as above).
Measured: Baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study start1 Jul 2010
- Primary completion11 Apr 2016
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,025 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Ravi Thadhani, Massachusetts General Hospital
- Investigators
- Ravi I Thadhani, MD, MPH, Principal investigator, Massachusetts General HospitalThomas J Wang, MD, Principal investigator, Vanderbilt University Medical CenterMichael H Picard, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630213
- Sponsor's protocol ID
- 2009P-001217
- Acronym
- VITAL-Echo
- Status last verified
- Apr 2022
- First submitted
- 25 Jun 2012
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 36285795
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Omega-3 Trial: Ancillary Study (VITAL-Echo) on the Impact of Vitamin D Supplementation on Cardiac Structure and Function
- ClinicalTrials.gov ID
- NCT01630213
- Acronym / sponsor ID
- VITAL-Echo / 2009P-001217
- Conditions
- Cardiovascular Disease
- Keywords
- Vitamin D3, Left ventricular mass, Echocardiography, Left ventricular systolic and diastolic function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,025 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 1 Jul 2010 (actual)
- Primary completion
- 11 Apr 2016 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 28 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 + fish oil/placebo | Active comparator | Dietary Supplement: Vitamin D3 + fish oil/fish oil placeboVitamin D3 2000 IU/day and fish oil (840 omega 3-fatty acids; Omacor)(or fish oil placebo)/day |
| Vitamin D3 placebo + fish oil/placebo | Placebo comparator | Dietary Supplement: Vitamin D3 placebo + fish oil/fish oil placeboVitamin D3 placebo + fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Have a pacemaker, prosthetic valve(s), surgical wires or other devices that could alter the echocardiographic image findings.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 + fish oil/fish oil placeboAlso: Cholecalciferol, OmacorVitamin D3 2000 IU/day and fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo per day | Dietary supplement | Vitamin D3 + fish oil/placebo |
| Vitamin D3 placebo + fish oil/fish oil placeboAlso: Vitamin D3 placebo, OmacorVitamin D3 placebo/day + fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo/day | Dietary supplement | Vitamin D3 placebo + fish oil/placebo |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 36285795Chandra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi I Thadhani, MD, MPH principal investigator
Massachusetts General Hospital
Thomas J Wang, MD principal investigator
Vanderbilt University Medical Center
Michael H Picard, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cardiovascular Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular (LV) mass (time frame: Baseline and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01630213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.