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This study will examine whether an intervention with vitamin D or fish oil supplements can reduce the risk of heart failure among adult men and women during a follow up period of up to five years (starting from the time of randomization into the parent VITAL trial). The investigators hypotheses are that both vitamin D and fish oil supplements will each reduce the risk of heart failure.
For this ancillary study of the ongoing parent VITAL trial, we will adjudicate incident heart failure cases occurring during a time period of up to five years starting from randomization of subjects in the parent VITAL study. Intention-to-treat analysis will be used to assess the efficacy of vitamin D as well as omega-3 fatty acids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D and fish oil | Experimental | 2000 IU per day and 1 g per day of fish oil |
|
| Vitamin D alone | Placebo Comparator | 2000 IU Vitamin D and fish oil placebo |
|
| Fish oil (EPA/DHA) alone | Experimental | 1 g per day of fish oil and vitamin D placebo |
|
| Fish oil and vitamin D placebo | Placebo Comparator | Placebo for both vitamin D and fish oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D and fish oil | Drug | 2000 IU vitamin D and 1g/d fish oil |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With New Heart Failure Hospitalization | We will consider any hospitalization for heart failure among participants enrolled in the parent VITAL trial for this ancillary study. Incident heart failure are initially captured through annual questionnaires with subsequent validation by a team of physicians with expertise in cardiovascular medicine and epidemiology. We excluded 36 participants with prevalent heart failure at the time of randomization for the primary analysis. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Recurrent Heart Failure Hospitalization | Recurrent heart failure hospitalizations ascertained either by review of medical records and/or use of CMS (Center for Medicare and Medicaid Services) data. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02120 | United States |
The trial included a 3-month placebo run-in period to select participants likely to have excellent compliance. Only individuals who reported taking at least 2/3 of their study pills during the run-in and met other eligibility criteria were randomized into the trial.
A total of 401605 adults were initially screened; 39430 eligible to enter run-in; 25871 eligible for randomization; 2x2 factorial design: 12927 assigned to active vit D (of these, 6463 were assigned to active omega-3 FAs and 6464 to placebo omega-3 FAs) & 12944 assigned to placebo vit D (of these, 6470 were assigned to active omega-3 FAs and 6474 to placebo omega-3 FAs)
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Vitamin D + Active Omega-3 Fatty Acids | Active Vitamin D = Vitamin D3, one 2000 IU capsule/day; Active Omega-3 Fatty Acids = Omacor, one 1-gram capsule/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 | Active Vitamin D + Placebo Omega-3 Fatty Acids | Active Vitamin D = Vitamin D3, one 2000 IU capsule/day; Placebo Omega-3 Fatty Acids, one capsule/day |
| FG002 | Placebo Vitamin D + Active Omega-3 Fatty Acids | Placebo Vitamin D, one capsule/day; Active Omega-3 Fatty Acids = Omacor, one 1-gram capsule/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]). |
| FG003 | Placebo Vitamin D + Placebo Omega-3 Fatty Acids | Placebo Vitamin D, one capsule/day; Placebo Omega-3 Fatty Acids, one capsule/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics of participants enrolled in the VITAL-Heart Failure ancillary study stratified by randomization arm
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Vitamin D + Active Omega-3 Fatty Acids | Active Vitamin D = Vitamin D3, one 2000 IU capsule/day; Active Omega-3 Fatty Acids = Omacor, one 1-gram capsule/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]). |
| BG001 |
| 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 New Heart Failure Hospitalization | We will consider any hospitalization for heart failure among participants enrolled in the parent VITAL trial for this ancillary study. Incident heart failure are initially captured through annual questionnaires with subsequent validation by a team of physicians with expertise in cardiovascular medicine and epidemiology. We excluded 36 participants with prevalent heart failure at the time of randomization for the primary analysis. | Posted | Count of Participants | Participants | 5 years |
|
5 years
Conditions monitored for Vit D: kidney stones, hypercalcemia, parathyroid disease, kidney failure or dialysis; Other symptoms/side effects: gastrointestinal (GI) bleed, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash Conditions monitored for omega-3: GI bleed; blood in urine; easy bruising; nosebleeds; kidney failure or dialysis; Other 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 | Active Vitamin D | Vitamin D3, one capsule of 2,000 IU/day | 485 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal bleeding | Blood and lymphatic system 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 | |
|---|---|---|---|---|
| Dr. Luc Djousse | Brigham and Women's Hospital | 617-525-7591 | ldjousse@rics.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 | Dec 31, 2020 | Feb 23, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D005395 | Fish Oils |
| D012847 | Single Person |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Fish oil (EPA/DHA) alone |
| Dietary Supplement |
1 g/d fish oil |
|
| Vitamin D alone | Drug | 2000 IU vitamin D |
|
| Placebo | Other | Vitamin D placebo and fish oil placebo |
|
| Active Vitamin D + Placebo Omega-3 Fatty Acids |
Active Vitamin D = Vitamin D3, one 2000 IU capsule/day; Placebo Omega-3 Fatty Acids, one capsule/day |
| BG002 | Placebo Vitamin D + Active Omega-3 Fatty Acids | Placebo Vitamin D, one capsule/day; Active Omega-3 Fatty Acids = Omacor, one 1-gram capsule/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]). |
| BG003 | Placebo Vitamin D + Placebo Omega-3 Fatty Acids | Placebo Vitamin D, one capsule/day; Placebo Omega-3 Fatty Acids, one capsule/day |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Not all participants reported race/ethnicity | Not all participants provided information on race/ethnicity; hence the discrepancy between number reported under race/ethnicity and total number enrolled. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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 |
|
|
|
| Secondary | Number of Recurrent Heart Failure Hospitalization | Recurrent heart failure hospitalizations ascertained either by review of medical records and/or use of CMS (Center for Medicare and Medicaid Services) data. | Each participant is allowed to have multiple heart failure hospitalizations. | Posted | Number | hospitalizations for heart failure | 5 years |
|
|
|
|
| 12,927 |
| 1,673 |
| 12,927 |
| 10,086 |
| 12,927 |
| EG001 | Vitamin D Placebo | Vitamin D placebo, 1 capsule/day | 493 | 12,944 | 1,659 | 12,944 | 10,098 | 12,944 |
| EG002 | Active Omega-3 Fatty Acids | Omacor, 1 g capsule/day Each capsule of Omacor contains 465 mg of eicosapentaenoic acid (EPA) and 375 mg of docosahexaenoic acid (DHA) | 493 | 12,933 | 1,613 | 12,933 | 10,094 | 12,933 |
| EG003 | Omega-3 Fatty Acids Placebo | Omega-3 fatty acids placebo, one capsule/day | 485 | 12,938 | 1,619 | 12,938 | 10,090 | 12,938 |
| Hypercalcemia | Endocrine disorders | Systematic Assessment |
|
| Invasive cancer of any type | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Death from cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Breast cancer in women | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Major cardiovascular events | Vascular disorders | Systematic Assessment | Composite of myocardial infarction, stroke, and cardiovascular death |
|
| Myocardial infarction | Vascular disorders | Systematic Assessment |
|
| Stroke | Vascular disorders | Systematic Assessment |
|
| Death from cardiovascular causes | Vascular 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 | hyperparathyroidism or hypoparathyroidism |
|
| Stomach upset or pain | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Increased burping | Gastrointestinal disorders | Systematic Assessment |
|
| Bad taste in mouth | General disorders | Systematic Assessment |
|
| Kidney stones | Renal and urinary disorders | Systematic Assessment |
|
| Kidney failure or dialysis | Renal and urinary disorders | Systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D009821 |
| Oils |
| D008055 | Lipids |
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
| Male |
|
| African American |
|
| Hispanic (not African American) |
|
| Asian/Pacific Islander |
|
| Native American/Alaskan Native |
|
| Other/Unknown |
|
| Hazard Ratio (HR) |
| 0.86 |
| 2-Sided |
| 95 |
| 0.74 |
| 0.998 |
| Superiority |