StrokeNCT04070833

Effects of Vitamin D and Omega-3 on Cerebrovascular Disease

A study testing Vitamin D and Fish oil in people with Stroke and Vitamin D, run by Brigham and Women's Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Stroke, Vitamin D
What is being tested?: Vitamin D and Fish oil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 290 participants
Where: No sites listed yet
Study dates: 1 Aug 2016to 17 Sep 2018
Phase: Interventional
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

Participants eligible and willing to participate in the main VITAL trial (NCT 01169259) who experience a stroke during follow-up.

Who cannot join

Participants eligible and willing to participate in the main VITAL trial (NCT 01169259) who do not experience a stroke during follow-up.

About this study

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a completed randomized clinical trial in 25,875 U.S. men and women which investigated whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduced the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. Observational follow-up of participants is currently ongoing. The current study is being conducted among participants in VITAL who experience a stroke event during follow-up and will examine whether vitamin D or omega-3 fatty acid supplementation impact post-stroke outcomes.

Read the detailed description

Stroke is a leading cause of disability and death worldwide and is expected to become an even more prevalent cause of disability in the future as the population ages. Understanding risk factors which may prospectively influence stroke outcomes may help to reduce the morbidity burden of stroke.

The VITamin D and OmegA-3 TriaL (VITAL) examined the impact of vitamin D3 (2,000 IU/day cholecalciferol) and omega-3 fatty acids (840 mg eicosapentaenoic acid [EPA] + docosahexaenoic acid [DHA]) on stroke incidence. However, the parent trial did not examine the impact of these supplements on stroke outcomes. Even if they do not significantly reduce stroke incidence, these supplements may still reduce stroke severity and improve outcomes post-stroke. Given the high morbidity burden of stroke, the impact of these supplements on stroke outcomes is of substantial scientific and public health importance.

The first aim of this study is to test whether vitamin D3 or omega-3 fatty acid supplementation reduces the risk of poor functional outcomes as measured at hospital discharge and 6- and 12-months post-stroke. The second aim is to determine whether chronic cerebrovascular changes (white matter hyperintensity volume and cerebral microbleeds) mediate the effect of vitamin D3 or omega-3 fatty acid supplementation on stroke outcomes.

Individuals enrolled in VITAL who experience a non-fatal stroke event will be mailed additional questionnaires assessing functional limitations, physical disability, and social disability. Responses from these questionnaires will be used to determine the effect of vitamin D3 or omega-3 fatty acid supplementation on post-stroke outcomes.

Conditions: Stroke, Vitamin D
Being tested: Vitamin D, Fish oil, Vitamin D placebo, Fish oil placebo
Keywords: stroke, stroke outcomes, vitamin D, omega-3 fatty acid
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin DDietary supplement
Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol
Fish oilDrug
Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
Vitamin D placeboDietary supplement
Vitamin D placebo
Fish oil placeboDrug
Fish oil placebo

Study groups in NCT04070833
Study group	Role	What they receive
Vitamin D + fish oil	Active comparator	Not described Receives: Dietary Supplement: Vitamin D; Drug: Fish oil
Vitamin D + fish oil placebo	Active comparator	Not described Receives: Dietary Supplement: Vitamin D; Drug: Fish oil placebo
Vitamin D placebo + fish oil	Active comparator	Not described Receives: Drug: Fish oil; Dietary Supplement: Vitamin D placebo
Vitamin D placebo + fish oil placebo	Placebo comparator	Not described Receives: Dietary Supplement: Vitamin D placebo; Drug: Fish oil placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Poor Stroke Outcome at Hospital Discharge as Measured by the Modified Rankin Scale (mR 3-6)
modified Rankin Scale (mRS) at hospital discharge
The mRS is often seen as a measure of disability or a "global health index" due to its strong emphasis on mobility although it claims to be a measure of handicap. The mRS is a seven-point scale (0=no symptoms at all; 1=no significant disability despite symptoms; 2=slight disability; 3=moderate disability; 4=moderately severe disability; 5=severe disability; 6=death). To avoid issues with model convergence due to sparse data, I will a priori categorize the mRS into good (mRS 0-2) versus poor (mRS 3-6) outcomes. These data were collected during the parent study (NCT01169259)
Measured: 1 day
Number of Participants With at Least One Functional Limitation After Stroke According to the Scale Adapted From Nagi
Functional limitations will be assessed through self-report using the physical performance scale adapted from Nagi. The adapted Nagi scale asks respondents if they experience any limitations in each of the following items: pulling or pushing large objects; stooping, crouching, or kneeling; reaching or extending arms above shoulder level; reaching or extending arms below shoulder level; writing or handling or fingering small objects; standing in one place for long periods; and sitting for an hour. Participants reporting a limitation in any of these items will be considered to have at least one functional limitation after stroke.
Measured: 1 year
Number of Participants With a Physical Disability After Stroke as Measured by the Modified Katz Activities of Daily Living (ADL) Scale
The modified Katz ADL scale ask participants to self-report if they need needing help with any of the following items: bathing; dressing; eating; getting in and out of a chair; and walking 50 yards. Individuals who report needing help with any of those items will be considered to have a physical disability after stroke.
Measured: 1 year
Number of Participants With a Physical Disability After Stroke as Measured by the Rosow-Breslau Functional Health Scale
The Rosow-Breslau Functional Health Scale asks participants to self-report if they need help with any of the following tasks: walking 0.5 mile; walking up and down stairs to the second floor; and doing heavy work around the house. Individuals who report needing help with any of those tasks will be considered to have a physical disability after stroke.
Measured: 1 year
Number of Participants With Social Disability After Stroke as Measured by FHS Social Disability Scale
Social disability was assessed through a self-administered questionnaire which asked questions about social functioning developed in the Framingham Heart Study. The scale covers five social areas (housekeeping, transportation, social interaction, food preparation, and grocery shopping). Respondents are grouped into four categories (need met, no apparent problem (best outcome); need met, potential problem; uncertain need met, potential problem; need unmet, current problem (worst outcome)) for each social area using a previously published algorithm.
We created summary indices for the total number of unmet needs across all areas and for the total number of unmet needs or uncertain needs met, potential problem. These indices range from 0 to 5, but to avoid problems with model convergence due to sparse data, we will a priori categorize them as 0 (best outcome), 1, or ≥2 (worst outcome).
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201617 Sep 2018

First posted28 Aug 2019
Study start1 Aug 2016
Primary completion17 Sep 2018
Study completion17 Sep 2018

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 StrokeStudies 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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04070833
Sponsor's protocol ID: K01HL128791
Other IDs: K01HL128791
Status last verified: Aug 2022
First submitted: 23 Aug 2019
Last updated: 15 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Investigators interested in using data from the parent study (VITAL) will be directed to contact the principal investigators of that study.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Vitamin D and Omega-3 on Cerebrovascular Disease
ClinicalTrials.gov ID: NCT04070833
Acronym / sponsor ID: K01HL128791
Conditions: Stroke, Vitamin D
Keywords: stroke, stroke outcomes, vitamin D, omega-3 fatty acid
Study type: Interventional
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 1 Aug 2016 (actual)
Primary completion: 17 Sep 2018 (actual)
Study completion: 17 Sep 2018 (actual)
First posted: 28 Aug 2019 (actual)
Results: Posted 15 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Vitamin D + fish oil	Active comparator	Dietary Supplement: Vitamin D, Drug: Fish oil
Vitamin D + fish oil placebo	Active comparator	Dietary Supplement: Vitamin D, Drug: Fish oil placebo
Vitamin D placebo + fish oil	Active comparator	Drug: Fish oil, Dietary Supplement: Vitamin D placebo
Vitamin D placebo + fish oil placebo	Placebo comparator	Dietary Supplement: Vitamin D placebo, Drug: Fish oil placebo

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Participants eligible and willing to participate in the main VITAL trial (NCT 01169259) who experience a stroke during follow-up.

Key exclusion criteria (1 listed)

Participants eligible and willing to participate in the main VITAL trial (NCT 01169259) who do not experience a stroke during follow-up.

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 DDietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol	Dietary supplement	Vitamin D + fish oil, Vitamin D + fish oil placebo
Fish oilDrug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])	Drug	Vitamin D + fish oil, Vitamin D placebo + fish oil
Vitamin D placeboVitamin D placebo	Dietary supplement	Vitamin D placebo + fish oil, Vitamin D placebo + fish oil placebo
Fish oil placeboFish oil placebo	Drug	Vitamin D + fish oil placebo, Vitamin D placebo + fish oil placebo

Primary outcome

Number of Participants With Poor Stroke Outcome at Hospital Discharge as Measured by the Modified Rankin Scale (mR 3-6)
Time frame: 1 day
modified Rankin Scale (mRS) at hospital discharge The mRS is often seen as a measure of disability or a "global health index" due to its strong emphasis on mobility although it claims to be a measure of handicap. The mRS is a seven-point scale (0=no symptoms at all; 1=no significant disability despite symptoms; 2=slight disability; 3=moderate disability; 4=moderately severe disability; 5=severe disability; 6=death). To avoid issues with model convergence due to sparse data, I will a priori categorize the mRS into good (mRS 0-2) versus poor (mRS 3-6) outcomes. These data were collected during the parent study (NCT01169259)
Number of Participants With at Least One Functional Limitation After Stroke According to the Scale Adapted From Nagi
Time frame: 1 year
Functional limitations will be assessed through self-report using the physical performance scale adapted from Nagi. The adapted Nagi scale asks respondents if they experience any limitations in each of the following items: pulling or pushing large objects; stooping, crouching, or kneeling; reaching or extending arms above shoulder level; reaching or extending arms below shoulder level; writing or handling or fingering small objects; standing in one place for long periods; and sitting for an hour. Participants reporting a limitation in any of these items will be considered to have at least one functional limitation after stroke.
Number of Participants With a Physical Disability After Stroke as Measured by the Modified Katz Activities of Daily Living (ADL) Scale
Time frame: 1 year
The modified Katz ADL scale ask participants to self-report if they need needing help with any of the following items: bathing; dressing; eating; getting in and out of a chair; and walking 50 yards. Individuals who report needing help with any of those items will be considered to have a physical disability after stroke.
Number of Participants With a Physical Disability After Stroke as Measured by the Rosow-Breslau Functional Health Scale
Time frame: 1 year
The Rosow-Breslau Functional Health Scale asks participants to self-report if they need help with any of the following tasks: walking 0.5 mile; walking up and down stairs to the second floor; and doing heavy work around the house. Individuals who report needing help with any of those tasks will be considered to have a physical disability after stroke.
Number of Participants With Social Disability After Stroke as Measured by FHS Social Disability Scale
Time frame: 1 year
Social disability was assessed through a self-administered questionnaire which asked questions about social functioning developed in the Framingham Heart Study. The scale covers five social areas (housekeeping, transportation, social interaction, food preparation, and grocery shopping). Respondents are grouped into four categories (need met, no apparent problem (best outcome); need met, potential problem; uncertain need met, potential problem; need unmet, current problem (worst outcome)) for each social area using a previously published algorithm. We created summary indices for the total number of unmet needs across all areas and for the total number of unmet needs or uncertain needs met, potential problem. These indices range from 0 to 5, but to avoid problems with model convergence due to sparse data, we will a priori categorize them as 0 (best outcome), 1, or ≥2 (worst outcome).

Results and safety

Results posted to the registry on 15 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vitamin D + Fish Oil	66	58
Vitamin D + Fish Oil Placebo	75	69
Vitamin D Placebo + Fish Oil	82	71
Vitamin D Placebo + Fish Oil Placebo	67	60

Primary outcome: Number of Participants With Poor Stroke Outcome at Hospital Discharge as Measured by the Modified Rankin Scale (mR 3-6)

Time frame: 1 day. Count of participants. Unit: Participants

Measure	Active Vitamin D n = 127	Vitamin D Placebo n = 131	Active Omega-3 Fatty Acids n = 129	Omega-3 Fatty Acids Placebo n = 129
Good outcome (mRS 0-2)	84	99	96	87
Poor outcome (mRS 3-6)	43	32	33	42

Population analysed: The overall Number of Participants Analyzed is less than the number of participants in the Participant Flow module because the mRS was missing for some participants.

Primary outcome: Number of Participants With at Least One Functional Limitation After Stroke According to the Scale Adapted From Nagi

Time frame: 1 year. Count of participants. Unit: Participants

Measure	Active Vitamin D n = 93	Vitamin D Placebo n = 104	Active Omega-3 Fatty Acids n = 99	Omega-3 Fatty Acids Placebo n = 98
Value	24	27	20	31

Population analysed: The overall Number of Participants Analyzed is less than the number of participants in the Participant Flow module because some individuals were missing information on this outcome. Individuals missing information on this outcome include those who experienced a fatal stroke and those who did not return the questionnaire assessing post-stroke outcomes which was mailed to stroke survivors.

Primary outcome: Number of Participants With a Physical Disability After Stroke as Measured by the Modified Katz Activities of Daily Living (ADL) Scale

Time frame: 1 year. Count of participants. Unit: Participants

Measure	Active Vitamin D n = 93	Vitamin D Placebo n = 104	Active Omega-3 Fatty Acids n = 99	Omega-3 Fatty Acids Placebo n = 98
Value	6	6	3	9

Primary outcome: Number of Participants With a Physical Disability After Stroke as Measured by the Rosow-Breslau Functional Health Scale

Time frame: 1 year. Count of participants. Unit: Participants

Measure	Active Vitamin D n = 93	Vitamin D Placebo n = 104	Active Omega-3 Fatty Acids n = 99	Omega-3 Fatty Acids Placebo n = 98
Value	45	53	42	56

Adverse events

Time frame: Up to 111 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vitamin D + Fish Oil	18 of 66 (27.3%)	16 of 66 (24.2%)	7 of 66
Vitamin D + Fish Oil Placebo	20 of 75 (26.7%)	16 of 75 (21.3%)	4 of 75
Vitamin D Placebo + Fish Oil	28 of 82 (34.1%)	17 of 82 (20.7%)	7 of 82
Vitamin D Placebo + Fish Oil Placebo	19 of 67 (28.4%)	15 of 67 (22.4%)	4 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Welcome to the VITAL Study WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No. Investigators interested in using data from the parent study (VITAL) will be directed to contact the principal investigators of that study.

Related trials for Stroke

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RecruitingObservational study
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Recruiting
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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.

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D and Fish oil in people with Stroke and Vitamin D, run by Brigham and Women's Hospital.

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 1 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 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 15 Aug 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 Poor Stroke Outcome at Hospital Discharge as Measured by the Modified Rankin Scale (mR 3-6) (time frame: 1 day). The study lists 5 primary outcomes in all. 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 NCT04070833.

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 15 Aug 2022.