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| ID | Type | Description | Link |
|---|---|---|---|
| K01HL128791 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D + fish oil | Active Comparator |
| |
| Vitamin D + fish oil placebo | Active Comparator |
| |
| Vitamin D placebo + fish oil | Active Comparator |
| |
| Vitamin D placebo + fish oil placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Label | URL |
|---|---|
| Welcome to the VITAL Study Website | View source |
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Investigators interested in using data from the parent study (VITAL) will be directed to contact the principal investigators of that study.
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This study only enrolled individuals from the main VITAL study who experienced a stroke during the main VITAL study. Therefore, although the main VITAL study enrolled 25871 individuals, the current study only includes the 290 individuals who experienced a stroke event during the main VITAL study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D + Fish Oil | Vitamin D: Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol Fish oil: 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]) |
| FG001 | Vitamin D + Fish Oil Placebo | Vitamin D: Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol Fish oil placebo: Fish oil placebo |
| FG002 | Vitamin D Placebo + Fish Oil | Fish oil: 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 placebo: Vitamin D placebo |
| FG003 | Vitamin D Placebo + Fish Oil Placebo | Vitamin D placebo: Vitamin D placebo Fish oil placebo: Fish oil placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D + Fish Oil | Vitamin D: Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol Fish oil: 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]) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | The overall Number of Participants Analyzed is less than the number of participants in the Participant Flow module because the mRS was missing for some participants. | Posted | Count of Participants | Participants | 1 day |
|
Up to 111 weeks
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash
Omega-3 fatty acid Monitored safety cond's: GI bleed; blood in urine; easy bruising; freq nosebleeds; kidney failure or dialysis; Other symptoms, side effects: stomach upset or pain; nausea; constipation; diarrhea; skin rash; bad taste in mouth; increased burping
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D + Fish Oil | Vitamin D: Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol Fish oil: 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]) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal bleeding | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Easy bruising | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela M. Rist | Brigham and Women's Hospital | 617-278-0835 | prist@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 13, 2021 | Sep 17, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| 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 placebo | Dietary Supplement | Vitamin D placebo |
|
| Fish oil placebo | Drug | Fish oil placebo |
|
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 |
| BG001 |
| Vitamin D + Fish Oil Placebo |
Vitamin D: Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol Fish oil placebo: Fish oil placebo |
| BG002 | Vitamin D Placebo + Fish Oil | Fish oil: 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 placebo: Vitamin D placebo |
| BG003 | Vitamin D Placebo + Fish Oil Placebo | Vitamin D placebo: Vitamin D placebo Fish oil placebo: Fish oil placebo |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Functional limitation at baseline | Count of Participants | Participants |
|
Vitamin D3, one 2000 IU capsule/day |
| OG001 | Vitamin D Placebo | Vitamin D placebo, one capsule/day |
| OG002 | Active Omega-3 Fatty Acids | Omacor, one 1-g capsule/day. Each capsule of Omacor contains 840 mg of marine omega-3 fatty acids (465 mg of EPA + 375 mg of DHA) |
| OG003 | Omega-3 Fatty Acids Placebo | Omega-3 fatty acids placebo, one capsule/day |
|
|
| Primary | 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. | The overall Number of Participants Analyzed is less than the number of participants in the Participant Flow module because some individuals were missing information on this outcome. Individuals missing information on this outcome include those who experienced a fatal stroke and those who did not return the questionnaire assessing post-stroke outcomes which was mailed to stroke survivors. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Primary | 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. | The overall Number of Participants Analyzed is less than the number of participants in the Participant Flow module because some individuals were missing information on this outcome. Individuals missing information on this outcome include those who experienced a fatal stroke and those who did not return the questionnaire assessing post-stroke outcomes which was mailed to stroke survivors. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Primary | 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. | The overall Number of Participants Analyzed is less than the number of participants in the Participant Flow module because some individuals were missing information on this outcome. Individuals missing information on this outcome include those who experienced a fatal stroke and those who did not return the questionnaire assessing post-stroke outcomes which was mailed to stroke survivors. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Primary | 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). | The overall Number of Participants Analyzed is less than the number of participants in the Participant Flow module because some individuals were missing information on this outcome. Individuals missing information on this outcome include those who experienced a fatal stroke and those who did not return the questionnaire assessing post-stroke outcomes which was mailed to stroke survivors. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 7 |
| 66 |
| 18 |
| 66 |
| 16 |
| 66 |
| EG001 | Vitamin D + Fish Oil Placebo | Vitamin D: Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol Fish oil placebo: Fish oil placebo | 4 | 75 | 20 | 75 | 16 | 75 |
| EG002 | Vitamin D Placebo + Fish Oil | Fish oil: 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 placebo: Vitamin D placebo | 7 | 82 | 28 | 82 | 17 | 82 |
| EG003 | Vitamin D Placebo + Fish Oil Placebo | Vitamin D placebo: Vitamin D placebo Fish oil placebo: Fish oil placebo | 4 | 67 | 19 | 67 | 15 | 67 |
| Hypercalcemia | Endocrine disorders | Systematic Assessment |
|
| Malignant Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Major CVD | Cardiac disorders | Systematic Assessment |
|
| Frequent nosebleeds | Blood and lymphatic system disorders | Systematic Assessment |
|
| Blood in urine | Blood and lymphatic system disorders | Systematic Assessment |
|
| Parathyroid condition | Endocrine disorders | Systematic Assessment |
|
| Kidney stones | Renal and urinary disorders | Systematic Assessment |
|
| Kidney failure or dialysis | Renal and urinary disorders | Systematic Assessment |
|
| Stomach upset or pain | Gastrointestinal disorders | Systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Bad taste in mouth | General disorders | Systematic Assessment |
|
| Increased burping | Gastrointestinal disorders | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009821 |
| Oils |
| D008055 | Lipids |
| 1 |
|
| 2 |
|
| Uncertain need met or unmet need |
|