Effects of Vitamin D and Omega-3 on Cerebrovascular Disease

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Status

Sponsorzy

Brigham and Women's Hospital

Współpracownicy

National Heart, Lung, and Blood Institute (NHLBI)

BADANIE KLINICZNE: NCT04070833

BioSeek: nct04070833

Słowa kluczowe

Abstrakcyjny

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.

Opis

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.

Daktyle

Ostatnia weryfikacja:	06/30/2020
Pierwsze przesłane:	08/22/2019
Szacowana liczba przesłanych rejestracji:	08/25/2019
Wysłany pierwszy:	08/27/2019
Ostatnia aktualizacja przesłana:	07/22/2020
Ostatnia opublikowana aktualizacja:	07/23/2020
Rzeczywista data rozpoczęcia badania:	08/22/2016
Szacowana data zakończenia podstawowej działalności:	04/29/2021
Szacowana data zakończenia badania:	04/29/2021

Stan lub choroba

Stroke

Vitamin D

Interwencja / leczenie

Dietary Supplement: Vitamin D

Drug: Fish oil

Dietary Supplement: Vitamin D placebo

Drug: Fish oil placebo

Faza

Grupy ramion

Ramię	Interwencja / leczenie
Active Comparator: Vitamin D + fish oil
Active Comparator: Vitamin D + fish oil placebo
Active Comparator: Vitamin D placebo + fish oil
Placebo Comparator: Vitamin D placebo + fish oil placebo

Kryteria kwalifikacji

Wiek kwalifikujący się do nauki	50 Years Do 50 Years
Płeć kwalifikująca się do nauki	All
Przyjmuje zdrowych wolontariuszy	tak
Kryteria	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.

Wynik

Podstawowe miary wyników

1. Stroke outcome at hospital discharge [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.

2. Functional limitations after stroke [1 year]

Functional limitations will be assessed through the physical performance scale adapted from Nagi. The adapted Nagi scale asks respondents if they experience limitations in: 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. First, we will dichotomize responses to each item as unlimited (no limitation) versus limited (any amount of limitation). Next, the full scale will be dichotomized into unlimited (no limitation in any of the items) versus limited (limitation in at least one item). This dichotomized version of the scale (no limitation in any of the items versus limitation in at least one item) will be our primary outcome.

3. Physical disability after stroke through the modified Katz Activities of Daily Living (ADL) Scale [1 year]

The modified Katz ADL scale asks about needing help with: bathing; dressing; eating; getting in and out of a chair; and walking 50 yards. First, we will dichotomize responses to each item as unlimited (no help needed) versus limited (any amount of help needed). Next, the full Katz scale (will be dichotomized into unlimited (no limitation in any of the items) versus limited (limitation in at least one item). This dichotomized version of the scale (no help needed versus any help needed) will be our primary outcome.

4. Physical disability after stroke through the Rosow-Breslau Functional Health Scale [1 year]

The Rosow-Breslau Functional Health Scale asks if the respondent needs help with the following gross mobility tasks: walking 0.5 mile; walking up and down stairs to the second floor; and doing heavy work around the house. First, we will dichotomize responses to each item as unlimited (no help needed) versus limited (any amount of help needed). Next, the full Rosow-Breslau Functional Health Scale scale (will be dichotomized into unlimited (no limitation in any of the items) versus limited (limitation in at least one item). This dichotomized version of the scale (no help needed versus any help needed) will be our primary outcome.

5. Social disability after stroke [1 year]

Social disability will be assessed using a scale 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; need met, potential problem; uncertain need met, potential problem; need unmet, current problem) for each social area using a previously published algorithm. We will examine each social area individually and create 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, 1, or ≥2.

Effects of Vitamin D and Omega-3 on Cerebrovascular Disease

Słowa kluczowe

omega 3 fatty acid

nowotwór złośliwy

udar mózgu

docosahexaenoic acid

eicosapentaenoic acid