Clinical trial NCT04070833: Effects of Vitamin D and Omega-3 on Cerebrovascular Disease
Official title: Effects of Vitamin D and Omega-3 on Cerebrovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Vitamin D
Keywords: stroke
stroke outcomes
vitamin D
omega-3 fatty acid
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-08-28
Enrollment: 290
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants With Poor Stroke Outcome at Hospital Discharge as Measured by the Modified Rankin Scale (mR 3-6)
timeFrame: 1 day
measure: Number of Participants With at Least One Functional Limitation After Stroke According to the Scale Adapted From Nagi
timeFrame: 1 year
measure: Number of Participants With a Physical Disability After Stroke as Measured by the Modified Katz Activities of Daily Living (ADL) Scale
timeFrame: 1 year
measure: Number of Participants With a Physical Disability After Stroke as Measured by the Rosow-Breslau Functional Health Scale
timeFrame: 1 year
measure: Number of Participants With Social Disability After Stroke as Measured by FHS Social Disability Scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
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