Vitamin D and Omega-3 Trial (VITAL) (VITAL)
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| ClinicalTrials.gov Identifier: NCT01169259 |
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Recruitment Status :
Active, not recruiting
First Posted : July 26, 2010
Results First Posted : January 6, 2020
Last Update Posted : March 7, 2024
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Sponsor:
Brigham and Women's Hospital
Collaborators:
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
Pharmavite LLC
Pronova BioPharma
BASF
Information provided by (Responsible Party):
JoAnn E. Manson, MD, Brigham and Women's Hospital
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention |
| Conditions |
Cancer Cardiovascular Disease |
| Interventions |
Dietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil) Dietary Supplement: Vitamin D3 placebo Dietary Supplement: Fish oil placebo |
| Enrollment | 25871 |
Participant Flow
| Recruitment Details | 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) |
| Pre-assignment Details | 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. |
| Arm/Group Title | ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids | ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids | PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids | PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids |
|---|---|---|---|---|
 Arm/Group Description |
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]). | ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day | 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]). | PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day |
| Period Title: Overall Study | ||||
| Started | 6463 | 6464 | 6470 | 6474 |
| Completed | 6463 | 6464 | 6470 | 6474 |
| Not Completed | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids | ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids | PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids | PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids | Total | |
|---|---|---|---|---|---|---|
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Arm/Group Description |
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]). | ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day | 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]). | PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day | Total of all reporting groups | |
| Overall Number of Baseline Participants | 6463 | 6464 | 6470 | 6474 | 25871 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 6463 participants | 6464 participants | 6470 participants | 6474 participants | 25871 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
2458 38.0%
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2462 38.1%
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2461 38.0%
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2467 38.1%
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9848 38.1%
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| >=65 years |
4005 62.0%
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4002 61.9%
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4009 62.0%
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4007 61.9%
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16023 61.9%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 6463 participants | 6464 participants | 6470 participants | 6474 participants | 25871 participants | |
| 67.1 (7.1) | 67.1 (7.0) | 67.2 (7.1) | 67.1 (7.1) | 67.1 (7.1) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 6463 participants | 6464 participants | 6470 participants | 6474 participants | 25871 participants | |
| Female |
3276 50.7%
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3271 50.6%
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3271 50.6%
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3267 50.5%
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13085 50.6%
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| Male |
3187 49.3%
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3193 49.4%
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3199 49.4%
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3207 49.5%
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12786 49.4%
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Race/Ethnicity, Customized
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Non-Hispanic white | Number Analyzed | 6329 participants | 6318 participants | 6324 participants | 6333 participants | 25304 participants |
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4515 71.3%
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4498 71.2%
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4529 71.6%
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4504 71.1%
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18046 71.3%
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| African American | Number Analyzed | 6329 participants | 6318 participants | 6324 participants | 6333 participants | 25304 participants |
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1278 20.2%
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1275 20.2%
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1271 20.1%
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1282 20.2%
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5106 20.2%
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| Hispanic (not African American) | Number Analyzed | 6329 participants | 6318 participants | 6324 participants | 6333 participants | 25304 participants |
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246 3.9%
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270 4.3%
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245 3.9%
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252 4.0%
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1013 4.0%
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| Asian/Pacific Islander | Number Analyzed | 6329 participants | 6318 participants | 6324 participants | 6333 participants | 25304 participants |
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102 1.6%
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86 1.4%
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98 1.5%
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102 1.6%
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388 1.5%
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| Native American/Alaskan Native | Number Analyzed | 6329 participants | 6318 participants | 6324 participants | 6333 participants | 25304 participants |
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62 1.0%
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56 0.9%
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58 0.9%
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52 0.8%
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228 0.9%
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| Other/unknown | Number Analyzed | 6329 participants | 6318 participants | 6324 participants | 6333 participants | 25304 participants |
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126 2.0%
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133 2.1%
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123 1.9%
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141 2.2%
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523 2.1%
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[1]
Measure Analysis Population Description: Not all participants reported race/ethnicity
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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| United States | Number Analyzed | 6463 participants | 6464 participants | 6470 participants | 6474 participants | 25871 participants |
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6463 100.0%
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6464 100.0%
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6470 100.0%
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6474 100.0%
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25871 100.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | VITAL Study Director |
| Organization: | Brigham and Women's Hospital; 900 Commonwealth Ave, 3rd fl.; Boston, MA 02215 |
| Phone: | 1-800-388-3963 |
| EMail: | vitalstudy@partners.org |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | JoAnn E. Manson, MD, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01169259 |
| Other Study ID Numbers: |
2009P-001217 U01CA138962 ( U.S. NIH Grant/Contract ) R01CA138962 ( U.S. NIH Grant/Contract ) |
| First Submitted: | January 13, 2010 |
| First Posted: | July 26, 2010 |
| Results First Submitted: | November 12, 2019 |
| Results First Posted: | January 6, 2020 |
| Last Update Posted: | March 7, 2024 |