Effects of Vitamin D and Omega-3 on Cerebrovascular Disease

Mass General Brigham

Status: Completed

Conditions: Stroke; Vitamin D

Treatments: Dietary Supplement: Vitamin D placebo; Dietary Supplement: Vitamin D; Drug: Fish oil placebo; Drug: Fish oil

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04070833

K01HL128791 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 290 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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290 participants in 4 patient groups, including a placebo group

Vitamin D + fish oil

Active Comparator group

Treatment:

Dietary Supplement: Vitamin D

Drug: Fish oil

Vitamin D + fish oil placebo

Active Comparator group

Treatment:

Drug: Fish oil placebo

Dietary Supplement: Vitamin D

Vitamin D placebo + fish oil

Active Comparator group

Treatment:

Dietary Supplement: Vitamin D placebo

Drug: Fish oil

Vitamin D placebo + fish oil placebo

Placebo Comparator group

Treatment:

Drug: Fish oil placebo

Dietary Supplement: Vitamin D placebo