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The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing 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 affect risk of infection and plasma hCAP18 levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D + fish oil | Active Comparator | vitamin D3 + Omacor |
|
| vitamin D + fish oil placebo | Active Comparator | vitamin D3 + fish oil placebo |
|
| vitamin D placebo + fish oil | Active Comparator | vitamin D placebo + Omacor |
|
| vitamin D placebo + fish oil placebo | Placebo Comparator | vitamin D placebo + fish oil placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D3 | Dietary Supplement | Vitamin D3 (cholecalciferol), 2000 IU per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| upper respiratory infection | one year | |
| hCAP-18 | one year |
| Measure | Description | Time Frame |
|---|---|---|
| lower respiratory infection | 5 years | |
| urinary tract infection | 5 years | |
| cellulitis |
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Participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study. Please see NCT 01169259 for lists of inclusion and exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21986389 | Background | Manson JE, Bassuk SS, Lee IM, Cook NR, Albert MA, Gordon D, Zaharris E, Macfadyen JG, Danielson E, Lin J, Zhang SM, Buring JE. The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease. Contemp Clin Trials. 2012 Jan;33(1):159-71. doi: 10.1016/j.cct.2011.09.009. Epub 2011 Oct 2. | |
| 26767629 |
| Label | URL |
|---|---|
| VITAL study website | View source |
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| omega-3 fatty acids (fish oil) | Drug | 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 D3 placebo | Dietary Supplement |
|
| fish oil placebo | Dietary Supplement |
|
| 5 years |
| antimicrobial-treated infection | 5 years |
| infection-related hospitalizations | 5 years |
| Background |
| Bassuk SS, Manson JE, Lee IM, Cook NR, Christen WG, Bubes VY, Gordon DS, Copeland T, Friedenberg G, D'Agostino DM, Ridge CY, MacFadyen JG, Kalan K, Buring JE. Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL). Contemp Clin Trials. 2016 Mar;47:235-43. doi: 10.1016/j.cct.2015.12.022. Epub 2016 Jan 6. |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D015525 | Fatty Acids, Omega-3 |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D009821 | Oils |
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