N/A
N=290
Effects of Vitamin D and Omega-3 on Cerebrovascular Disease
Stroke · Vitamin D
Bottom Line
View on ClinicalTrials.gov: NCT04070833 ↗Enrolled (actual)
290
Serious AEs
29.3%
Results posted
Aug 2022
Primary outcome: Primary: Number of Participants With Poor Stroke Outcome at Hospital Discharge as Measured by the Modified Rankin Scale (mR 3-6) — 84; 99; 96; 87 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vitamin D (Dietary_supplement); Fish oil (Drug); Vitamin D placebo (Dietary_supplement); Fish oil placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Poor Stroke Outcome at Hospital Discharge as Measured by the Modified Rankin Scale (mR 3-6) |
84; 99; 96; 87; 43; 32 | — |
| PRIMARY Number of Participants With at Least One Functional Limitation After Stroke According to the Scale Adapted From Nagi |
24; 27; 20; 31 | — |
| PRIMARY Number of Participants With a Physical Disability After Stroke as Measured by the Modified Katz Activities of Daily Living (ADL) Scale |
6; 6; 3; 9 | — |
| PRIMARY Number of Participants With a Physical Disability After Stroke as Measured by the Rosow-Breslau Functional Health Scale |
45; 53; 42; 56 | — |
| PRIMARY Number of Participants With Social Disability After Stroke as Measured by FHS Social Disability Scale |
81; 98; 92; 87; 10; 5 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04070833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.