Heart FailurePhase 3NCT02271230
Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure
A Phase 3 study testing Vitamin D and fish oil, Fish oil (EPA/DHA) alone and Vitamin D alone in people with Heart Failure, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study will examine whether an intervention with vitamin D or fish oil supplements can reduce the risk of heart failure among adult men and women during a follow up period of up to five years (starting from the time of randomization into the parent VITAL trial). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Vitamin D and fish oil, Fish oil (EPA/DHA) alone and Vitamin D alone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25,871 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged 50 or older or women aged 55 or older
- Be consuming no more than 800 IU of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium+vitamin D supplements, medications with vitamin D [e.g., Fosamax Plus D], and multivitamins), or, if taking, willing to decrease or forego such use during the trial;
- Be consuming no more than 1200 mg/d of calcium from all supplemental sources combined, or, if taking, willing to decrease or forego such use during the trial;
- Not be taking fish oil supplements, or, if taking, willing to forego their use during the trial
Who cannot join
- prevalent heart failure
- History of cancer (except non-melanoma skin cancer), heart attack, stroke, transient ischemic attack, angina pectoris, CABG, or PCI
- History of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or Wegener's granulomatosis;
- Allergy to fish or soy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
This study will examine whether an intervention with vitamin D or fish oil supplements can reduce the risk of heart failure among adult men and women during a follow up period of up to five years (starting from the time of randomization into the parent VITAL trial). The investigators hypotheses are that both vitamin D and fish oil supplements will each reduce the risk of heart failure.
Read the detailed description
For this ancillary study of the ongoing parent VITAL trial, we will adjudicate incident heart failure cases occurring during a time period of up to five years starting from randomization of subjects in the parent VITAL study. Intention-to-treat analysis will be used to assess the efficacy of vitamin D as well as omega-3 fatty acids.
- Conditions
- Heart Failure
- Being tested
- Vitamin D and fish oil, Fish oil (EPA/DHA) alone, Vitamin D alone, Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D and fish oilDrug
2000 IU vitamin D and 1g/d fish oil
Fish oil (EPA/DHA) aloneDietary supplement
1 g/d fish oil
Vitamin D aloneDrug
2000 IU vitamin D
PlaceboOther
Vitamin D placebo and fish oil placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D and fish oil | Experimental | 2000 IU per day and 1 g per day of fish oil Receives: Drug: Vitamin D and fish oil |
| Vitamin D alone | Placebo comparator | 2000 IU Vitamin D and fish oil placebo Receives: Drug: Vitamin D alone |
| Fish oil (EPA/DHA) alone | Experimental | 1 g per day of fish oil and vitamin D placebo Receives: Dietary Supplement: Fish oil (EPA/DHA) alone |
| Fish oil and vitamin D placebo | Placebo comparator | Placebo for both vitamin D and fish oil Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With New Heart Failure Hospitalization
We will consider any hospitalization for heart failure among participants enrolled in the parent VITAL trial for this ancillary study. Incident heart failure are initially captured through annual questionnaires with subsequent validation by a team of physicians with expertise in cardiovascular medicine and epidemiology. We excluded 36 participants with prevalent heart failure at the time of randomization for the primary analysis.
Measured: 5 years
Secondary outcomes (1)
Number of Recurrent Heart Failure Hospitalization
Recurrent heart failure hospitalizations ascertained either by review of medical records and/or use of CMS (Center for Medicare and Medicaid Services) data.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25,871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Djousse, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271230
- Sponsor's protocol ID
- 2014P001206
- Status last verified
- Feb 2022
- First submitted
- 7 Oct 2014
- Last updated
- 18 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention With Vitamin D and Omega-3 Supplements and Incident Heart Failure
- ClinicalTrials.gov ID
- NCT02271230
- Acronym / sponsor ID
- 2014P001206
- Conditions
- Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25,871 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Posted 18 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine whether an intervention with vitamin D or fish oil supplements can reduce the risk of heart failure among adult men and women during a follow up period of up to five years (starting from the time of randomization into the parent VITAL trial). The investigators hypotheses are that both vitamin D and fish oil supplements will each reduce the risk of heart failure.
Detailed description
For this ancillary study of the ongoing parent VITAL trial, we will adjudicate incident heart failure cases occurring during a time period of up to five years starting from randomization of subjects in the parent VITAL study. Intention-to-treat analysis will be used to assess the efficacy of vitamin D as well as omega-3 fatty acids.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin D and fish oil | Experimental | Drug: Vitamin D and fish oil2000 IU per day and 1 g per day of fish oil |
| Vitamin D alone | Placebo comparator | Drug: Vitamin D alone2000 IU Vitamin D and fish oil placebo |
| Fish oil (EPA/DHA) alone | Experimental | Dietary Supplement: Fish oil (EPA/DHA) alone1 g per day of fish oil and vitamin D placebo |
| Fish oil and vitamin D placebo | Placebo comparator | Other: PlaceboPlacebo for both vitamin D and fish oil |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men aged 50 or older or women aged 55 or older
- Be consuming no more than 800 IU of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium+vitamin D supplements, medications with vitamin D [e.g., Fosamax Plus D], and multivitamins), or, if taking, willing to decrease or forego such use during the trial;
- Be consuming no more than 1200 mg/d of calcium from all supplemental sources combined, or, if taking, willing to decrease or forego such use during the trial;
- Not be taking fish oil supplements, or, if taking, willing to forego their use during the trial
Key exclusion criteria (4 listed)
- prevalent heart failure
- History of cancer (except non-melanoma skin cancer), heart attack, stroke, transient ischemic attack, angina pectoris, CABG, or PCI
- History of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or Wegener's granulomatosis;
- Allergy to fish or soy
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 D and fish oil2000 IU vitamin D and 1g/d fish oil | Drug | Vitamin D and fish oil |
| Fish oil (EPA/DHA) alone1 g/d fish oil | Dietary supplement | Fish oil (EPA/DHA) alone |
| Vitamin D alone2000 IU vitamin D | Drug | Vitamin D alone |
| PlaceboVitamin D placebo and fish oil placebo | Other | Fish oil and vitamin D placebo |
Primary outcome
Number of Participants With New Heart Failure Hospitalization
Time frame: 5 years
We will consider any hospitalization for heart failure among participants enrolled in the parent VITAL trial for this ancillary study. Incident heart failure are initially captured through annual questionnaires with subsequent validation by a team of physicians with expertise in cardiovascular medicine and epidemiology. We excluded 36 participants with prevalent heart failure at the time of randomization for the primary analysis.
1 secondary outcome
Number of Recurrent Heart Failure Hospitalization
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D and fish oil, Fish oil (EPA/DHA) alone and Vitamin D alone in people with Heart Failure, run by Brigham and Women's 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 4 inclusion and 4 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 18 Mar 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With New Heart Failure Hospitalization (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2022.