Effects of Vitamin D and Omega-3 on Cerebrovascular Disease

NCT04070833 | Completed Results

• 1 other identifier: K01HL128791
• Study Type: interventional
• Target: 290
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke; Vitamin D

Keywords

stroke; stroke outcomes; vitamin D; omega-3 fatty acid

Outcome Measures

Primary Outcomes (5)

• 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)

  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.

  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.

  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.

  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).

  1 year

Study Arms (4)

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

Interventions

Vitamin D DIETARY_SUPPLEMENT

Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol

Vitamin D + fish oil; Vitamin D + fish oil placebo

Fish oil DRUG

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 + fish oil; Vitamin D placebo + fish oil

Vitamin D placebo DIETARY_SUPPLEMENT

Vitamin D placebo

Vitamin D placebo + fish oil; Vitamin D placebo + fish oil placebo

Fish oil placebo DRUG

Fish oil placebo

Vitamin D + fish oil placebo; Vitamin D placebo + fish oil placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Related Links

• Welcome to the VITAL Study Website

MeSH Terms

Conditions

Stroke

Interventions

Vitamin D; Fish Oils

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Oils; Lipids

Results Point of Contact

• Title: Pamela M. Rist
• Organization: Brigham and Women's Hospital

prist@bwh.harvard.edu

617-278-0835

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Epidemiologist

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: August 1, 2016
• Primary Completion: September 17, 2018
• Study Completion: September 17, 2018
• Last Updated: August 15, 2022
• Results First Posted: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share