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| ID | Type | Description | Link |
|---|---|---|---|
| R01EY021900 | U.S. NIH Grant/Contract | View source | |
| 2012P000724 | Other Identifier | Brigham and Women's Hospital |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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The VITamin D and OmegA-3 Trial (VITAL; NCT 01169259) is a randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or omega-3 fatty acids, compared to placebo, reduce the incidence and/or progression of age-related macular degeneration (AMD).
This ancillary study to the VITamin D and OmegA-3 TriaL (VITAL) will examine whether vitamin D3 and omega-3 fatty acids can help prevent the onset or progression of age-related macular degeneration (AMD). The study will also examine whether vitamin D3 and omega-3 fatty acids interact with each other, or with specific genes associated with AMD or vitamin D3 or omega-3 fatty acid metabolic activity, to affect the risk of developing AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D + fish oil placebo | Active Comparator | Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo |
|
| Vitamin D placebo + fish oil | Active Comparator | Vitamin D placebo 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 + fish oil placebo | Placebo Comparator | Vitamin D placebo fish oil placebo |
|
| Vitamin D + fish oil | Active Comparator | Vitamin D (cholecalciferol), 2000 IU per day 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]) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 fatty acids (fish oil) | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an AMD Event | AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Incident Visually-Significant AMD | AMD responsible for a reduction in best-corrected visual acuity to 20/30 or worse | 5 years |
| Number of Participants With Incident Advanced AMD |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Incident AMD | Incident AMD with or without vision loss to 20/30 or worse; a component of the composite end point of AMD Events | 5 years |
| Number of Participants With AMD Progression |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra A Schaumberg, ScD | Brigham and Women's Hospital | Principal Investigator |
| William G Christen, ScD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33119047 | Derived | Christen WG, Cook NR, Manson JE, Buring JE, Chasman DI, Lee IM, Bubes V, Li C, Haubourg M, Schaumberg DA; VITAL Research Group. Effect of Vitamin D and omega-3 Fatty Acid Supplementation on Risk of Age-Related Macular Degeneration: An Ancillary Study of the VITAL Randomized Clinical Trial. JAMA Ophthalmol. 2020 Dec 1;138(12):1280-1289. doi: 10.1001/jamaophthalmol.2020.4409. |
| Label | URL |
|---|---|
| VITAL study website | View source |
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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.
401605 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 | Vitamin D + Fish Oil | Vitamin D (cholecalciferol), 2000 IU per day 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]) Omega-3 fatty acids (fish oil) Vitamin D3 |
| FG001 | Vitamin D + Fish Oil Placebo | Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo Vitamin D3 Fish oil placebo |
| FG002 | Vitamin D Placebo + Fish Oil | Vitamin D placebo 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]) Omega-3 fatty acids (fish oil) Vitamin D3 placebo |
| FG003 | Vitamin D Placebo + Fish Oil Placebo | Vitamin D placebo fish oil placebo Vitamin D3 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 (cholecalciferol), 2000 IU per day 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]) Omega-3 fatty acids (fish oil) Vitamin D3 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 an AMD Event | AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline | Posted | Count of Participants | Participants | 5 years |
|
5 years
Vit D Monitored safety cond'ns: hypercalcemia, kidney stones, parathyroid disease, kidney failure or dialysis; Other symptoms, side effects: GI bleeding, easy bruising; stomach upset or pain; nausea; constipation, diarrhea, skin rash.
Omega-3 FA Monitored safety cond'ns: GI bleeding; 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 | Active Vitamin D/Active Omega-3 Fatty Acids | Vitamin D3 (one 2000 IU capsule/day) + 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). |
| 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 | |
|---|---|---|---|---|
| VITAL Study Director | Brigham and Women's Hospital; 900 Commonwealth Ave, 3rd fl.; Boston, MA 02215 | 1-800-388-3963 | vitalstudy@partners.org |
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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 | Mar 29, 2012 | Oct 27, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D005395 | Fish Oils |
| C405603 | Omacor |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Vitamin D3 |
| Dietary Supplement |
|
|
| Vitamin D3 placebo | Dietary Supplement |
|
| Fish oil placebo | Dietary Supplement |
|
| 5 years |
Progression to advanced AMD among participants with AMD at baseline; a component of the composite end point of AMD Events
| 5 years |
| Number of Participants With an AMD Event, Excluding the First Two Years of Follow-up | AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline | 5 years (excluding the first two years of follow-up) |
| Vitamin D + Fish Oil Placebo |
Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo Vitamin D3 Fish oil placebo |
| BG002 | Vitamin D Placebo + Fish Oil | Vitamin D placebo 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]) Omega-3 fatty acids (fish oil) Vitamin D3 placebo |
| BG003 | Vitamin D Placebo + Fish Oil Placebo | Vitamin D placebo fish oil placebo Vitamin D3 placebo Fish oil placebo |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Not all participants reported race/ethnicity. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Omega-3 Fatty Acids Placebo | Omega-3 fatty acids placebo, one capsule/day |
|
|
|
| Secondary | Number of Participants With Incident Visually-Significant AMD | AMD responsible for a reduction in best-corrected visual acuity to 20/30 or worse | Posted | Count of Participants | Participants | 5 years |
|
|
|
|
| Secondary | Number of Participants With Incident Advanced AMD | Posted | Count of Participants | Participants | 5 years |
|
|
|
|
| Other Pre-specified | Number of Participants With Incident AMD | Incident AMD with or without vision loss to 20/30 or worse; a component of the composite end point of AMD Events | Posted | Count of Participants | Participants | 5 years |
|
|
|
|
| Other Pre-specified | Number of Participants With AMD Progression | Progression to advanced AMD among participants with AMD at baseline; a component of the composite end point of AMD Events | Posted | Count of Participants | Participants | 5 years |
|
|
|
|
| Other Pre-specified | Number of Participants With an AMD Event, Excluding the First Two Years of Follow-up | AMD Event = a composite endpoint of incident AMD plus cases of progression to advanced AMD among participants with AMD at baseline | Posted | Count of Participants | Participants | 5 years (excluding the first two years of follow-up) |
|
|
|
|
| 241 |
| 6,463 |
| 791 |
| 6,463 |
| 5,101 |
| 6,463 |
| EG001 | Active Vitamin D/Placebo Omega-3 Fatty Acids | Vitamin D3, one 2000 IU capsule/day + Omega-3 fatty acids placebo, one capsule/day | 244 | 6,464 | 782 | 6,464 | 5,027 | 6,464 |
| EG002 | Placebo Vitamin D/Active Omega-3 Fatty Acids | Vitamin D placebo, one capsule/day + 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). | 252 | 6,470 | 822 | 6,470 | 5,037 | 6,470 |
| EG003 | Placebo Vitamin D/Placebo Omega-3 Fatty Acids | Vitamin D placebo, one capsule/day + Omega-3 fatty acids placebo, one capsule/day | 241 | 6,474 | 837 | 6,474 | 5,101 | 6,474 |
| Hypercalcemia | Endocrine disorders | Systematic Assessment |
|
| Invasive cancer of any type | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Total cancer=invasive cancer of any type |
|
| 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 (in men) | 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 event | Vascular disorders | Systematic Assessment | Major cardiovascular event = a composite endpoint of myocardial infarction, stroke, and death from cardiovascular causes |
|
| 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 | Parathyroid condition = 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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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D009821 | Oils |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| African-American |
|
| Hispanic (Not African-American) |
|
| Asian/Pacific Islander |
|
| Native American/Alaskan Native |
|
| Other/Unknown |
|
| Hazard Ratio (HR) |
| 0.84 |
| 2-Sided |
| 95 |
| 0.59 |
| 1.17 |
| Superiority |
| Hazard Ratio (HR) |
| 0.72 |
| 2-Sided |
| 95 |
| 0.48 |
| 1.09 |
| Superiority |
| Hazard Ratio (HR) |
| 0.93 |
| 2-Sided |
| 95 |
| 0.73 |
| 1.17 |
| Superiority |
| Hazard Ratio (HR) |
| 1.05 |
| 2-Sided |
| 95 |
| 0.56 |
| 1.97 |
| Superiority |
| Hazard Ratio (HR) |
| 0.90 |
| 2-Sided |
| 95 |
| 0.67 |
| 1.21 |
| Superiority |