Trial Outcomes & Findings for VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL (NCT NCT01696435)
NCT ID: NCT01696435
Last Updated: 2025-12-10
Results Overview
Depression syndrome will be determined by presence of clinical diagnosis, treatment and/or above-threshold symptoms on mood questionnaire (e.g., PHQ) items. This is an event outcome, where the depression event was defined as a new self-report of physician/clinician-diagnosed depression, treatment (medication and/or counseling) for depression, or presence of clinically relevant depressive symptoms (PHQ-8 total score \>=10 points) on the annual study questionnaires that were administered over a median 5.3 years of randomized treatment and follow-up. Participants were followed for the depression event until the occurrence of the endpoint, death, or the end of the trial, whichever came first. The Outcome Measure table shows the counts of depression events in each randomized group by treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18353 participants
Primary outcome timeframe
From date of randomization until the date of the occurrence of the endpoint, death, or the end of the trial, whichever came first, assessed up to a median of 5.3 years of follow-up
Results posted on
2025-12-10
Participant Flow
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 assigned to active omega-3 FAs and 6464 to placebo omega-3 FAs) \& 12944 assigned to placebo vit D (of these, 6470 assigned to active omega-3 FAs and 6474 to placebo omega-3 FAs). Additional 7518 excluded per VITAL-DEP eligibility criteria; 18353 at risk for depression during follow-up.
The trial included a 3-month placebo run-in period to select participants likely to have adequate compliance. Only individuals who reported taking at least 2/3 of their study pills during the placebo run-in and met other eligibility criteria were randomized into the trial.
Participant milestones
| Measure |
Vitamin D + Fish Oil Placebo
Vitamin D3 (cholecalciferol), 2000 IU per day
Fish oil placebo
vitamin D3: Vitamin D3 (cholecalciferol), 2000 IU per day
Fish oil placebo: Fish oil placebo
|
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): 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
|
Vitamin D Placebo + Fish Oil Placebo
Vitamin D placebo
Fish oil placebo
Fish oil placebo: Fish oil placebo
Vitamin D placebo: Vitamin D placebo
|
Vitamin D + Fish Oil
Vitamin D3 (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 \[DHA\])
vitamin D3: Vitamin D3 (cholecalciferol), 2000 IU per day
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 \[DHA\]).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4573
|
4563
|
4609
|
4608
|
|
Overall Study
COMPLETED
|
4573
|
4563
|
4609
|
4608
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL
Baseline characteristics by cohort
| Measure |
Vitamin D + Fish Oil Placebo
n=4573 Participants
Vitamin D3 (cholecalciferol), 2000 IU per day
Fish oil placebo
vitamin D3: Vitamin D3 (cholecalciferol), 2000 IU per day
Fish oil placebo: Fish oil placebo
|
Vitamin D Placebo + Fish Oil
n=4563 Participants
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): 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
|
Vitamin D Placebo + Fish Oil Placebo
n=4609 Participants
Vitamin D placebo
Fish oil placebo
Fish oil placebo: Fish oil placebo
Vitamin D placebo: Vitamin D placebo
|
Vitamin D + Fish Oil
n=4608 Participants
Vitamin D3 (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 \[DHA\])
vitamin D3: Vitamin D3 (cholecalciferol), 2000 IU per day
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 \[DHA\]).
|
Total
n=18353 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=681 Participants
|
0 Participants
n=639 Participants
|
0 Participants
n=277 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1642 Participants
n=4 Participants
|
1657 Participants
n=50 Participants
|
1674 Participants
n=681 Participants
|
1644 Participants
n=639 Participants
|
6617 Participants
n=277 Participants
|
|
Age, Categorical
>=65 years
|
2931 Participants
n=4 Participants
|
2906 Participants
n=50 Participants
|
2935 Participants
n=681 Participants
|
2964 Participants
n=639 Participants
|
11736 Participants
n=277 Participants
|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 7.0 • n=4 Participants
|
67.4 years
STANDARD_DEVIATION 7.1 • n=50 Participants
|
67.5 years
STANDARD_DEVIATION 7.0 • n=681 Participants
|
67.5 years
STANDARD_DEVIATION 7.1 • n=639 Participants
|
67.5 years
STANDARD_DEVIATION 7.1 • n=277 Participants
|
|
Sex: Female, Male
Female
|
2261 Participants
n=4 Participants
|
2218 Participants
n=50 Participants
|
2265 Participants
n=681 Participants
|
2279 Participants
n=639 Participants
|
9023 Participants
n=277 Participants
|
|
Sex: Female, Male
Male
|
2312 Participants
n=4 Participants
|
2345 Participants
n=50 Participants
|
2344 Participants
n=681 Participants
|
2329 Participants
n=639 Participants
|
9330 Participants
n=277 Participants
|
|
Race/Ethnicity, Customized
Total
|
4573 Participants
n=4 Participants
|
4563 Participants
n=50 Participants
|
4609 Participants
n=681 Participants
|
4608 Participants
n=639 Participants
|
18353 Participants
n=277 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
3255 Participants
n=4 Participants
|
3266 Participants
n=50 Participants
|
3279 Participants
n=681 Participants
|
3297 Participants
n=639 Participants
|
13097 Participants
n=277 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
855 Participants
n=4 Participants
|
833 Participants
n=50 Participants
|
869 Participants
n=681 Participants
|
850 Participants
n=639 Participants
|
3407 Participants
n=277 Participants
|
|
Race/Ethnicity, Customized
Hispanic (not Black or African-American)
|
185 Participants
n=4 Participants
|
170 Participants
n=50 Participants
|
176 Participants
n=681 Participants
|
177 Participants
n=639 Participants
|
708 Participants
n=277 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
66 Participants
n=4 Participants
|
72 Participants
n=50 Participants
|
78 Participants
n=681 Participants
|
78 Participants
n=639 Participants
|
294 Participants
n=277 Participants
|
|
Race/Ethnicity, Customized
Native American or Alaskan Native
|
37 Participants
n=4 Participants
|
39 Participants
n=50 Participants
|
33 Participants
n=681 Participants
|
41 Participants
n=639 Participants
|
150 Participants
n=277 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
175 Participants
n=4 Participants
|
183 Participants
n=50 Participants
|
174 Participants
n=681 Participants
|
165 Participants
n=639 Participants
|
697 Participants
n=277 Participants
|
|
Region of Enrollment
United States
|
4573 participants
n=4 Participants
|
4563 participants
n=50 Participants
|
4609 participants
n=681 Participants
|
4608 participants
n=639 Participants
|
18353 participants
n=277 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of the occurrence of the endpoint, death, or the end of the trial, whichever came first, assessed up to a median of 5.3 years of follow-upPopulation: Analysis population reflects the randomized groups by treatment agents, as all published analyses per protocol were conducted comparing active treatment to placebo. These groups were: n=9181 randomized to active vitamin D and n=9172 randomized to vitamin D placebo; n=9171 randomized to active fish oil and n=9182 randomized to fish oil placebo. Per intervention results are presented for active vitamin D vs. matching vitamin D placebo and for active fish oil vs. matching fish oil placebo.
Depression syndrome will be determined by presence of clinical diagnosis, treatment and/or above-threshold symptoms on mood questionnaire (e.g., PHQ) items. This is an event outcome, where the depression event was defined as a new self-report of physician/clinician-diagnosed depression, treatment (medication and/or counseling) for depression, or presence of clinically relevant depressive symptoms (PHQ-8 total score \>=10 points) on the annual study questionnaires that were administered over a median 5.3 years of randomized treatment and follow-up. Participants were followed for the depression event until the occurrence of the endpoint, death, or the end of the trial, whichever came first. The Outcome Measure table shows the counts of depression events in each randomized group by treatment.
Outcome measures
| Measure |
Active Vitamin D
n=9181 Participants
Vitamin D3: Vitamin D3 (cholecalciferol), one 2000 IU capsule per day
|
Vitamin D Placebo
n=9172 Participants
Vitamin D placebo: Vitamin D placebo, one capsule per day
|
Active Fish Oil
n=9171 Participants
Fish oil: Omacor, one 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 \[DHA\])
|
Fish Oil Placebo
n=9182 Participants
Fish oil placebo: Fish oil placebo, one capsule per day
|
|---|---|---|---|---|
|
Number of Participants With a Depression Event
|
609 Participants
|
625 Participants
|
651 Participants
|
583 Participants
|
PRIMARY outcome
Timeframe: Baseline, follow-up year 1, follow-up year 2, follow-up year 3, follow-up year 4, and follow-up year 5Population: Analysis population reflects the randomized groups by treatment agents, as all published analyses per protocol were conducted comparing active treatment to placebo. These were n=9181 randomized to active vitamin D; n=9172 randomized to vitamin D placebo; n=9171 randomized to active fish oil; n=9182 randomized to fish oil placebo. Per intervention results are presented for active treatment vs placebo. Each row shows exact number of participants providing responses to the PHQ-8 at that timepoint.
Mood scores are evaluated by the 8-item Patient Health Questionnaire (PHQ-8). The measured outcome was the total PHQ-8 score. The PHQ-8 includes items corresponding to the criteria for major depression. Each of the 8 items can be scored as 0, 1, 2, or 3 points (higher score means worse symptoms). The 8 items are summed to a total PHQ-8 score. The range for the PHQ-8 score is 0-24 points; higher scores denote worse mood or depressive symptoms. The PHQ-8 was measured annually at baseline and at up to 5 follow-up times (for a maximum of 6 time points). Data from all time points was used to determine the mean differences in change in mood scores over all follow-up by randomized treatment. Per protocol, the Statistical Analysis section shows the results for the primary outcome of mean difference in overall change in PHQ-8 scores comparing active and placebo groups (for each agent).
Outcome measures
| Measure |
Active Vitamin D
n=9181 Participants
Vitamin D3: Vitamin D3 (cholecalciferol), one 2000 IU capsule per day
|
Vitamin D Placebo
n=9172 Participants
Vitamin D placebo: Vitamin D placebo, one capsule per day
|
Active Fish Oil
n=9171 Participants
Fish oil: Omacor, one 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 \[DHA\])
|
Fish Oil Placebo
n=9182 Participants
Fish oil placebo: Fish oil placebo, one capsule per day
|
|---|---|---|---|---|
|
Mood Scores
Baseline adjusted mean
|
1.08 score on a scale
Interval 1.05 to 1.11
|
1.13 score on a scale
Interval 1.09 to 1.16
|
1.09 score on a scale
Interval 1.06 to 1.13
|
1.11 score on a scale
Interval 1.08 to 1.15
|
|
Mood Scores
Mean change at Year 2
|
0.07 score on a scale
Interval 0.03 to 0.11
|
0.04 score on a scale
Interval 0.0 to 0.08
|
0.07 score on a scale
Interval 0.03 to 0.11
|
0.04 score on a scale
Interval 0.0 to 0.08
|
|
Mood Scores
Mean change at Year 3
|
0.09 score on a scale
Interval 0.05 to 0.13
|
0.07 score on a scale
Interval 0.03 to 0.12
|
0.10 score on a scale
Interval 0.06 to 0.15
|
0.06 score on a scale
Interval 0.02 to 0.1
|
|
Mood Scores
Mean change at Year 4
|
0.06 score on a scale
Interval 0.02 to 0.1
|
0.07 score on a scale
Interval 0.03 to 0.11
|
0.08 score on a scale
Interval 0.04 to 0.12
|
0.05 score on a scale
Interval 0.01 to 0.09
|
|
Mood Scores
Mean change at Year 5
|
0.20 score on a scale
Interval 0.15 to 0.25
|
0.16 score on a scale
Interval 0.11 to 0.22
|
0.18 score on a scale
Interval 0.13 to 0.23
|
0.19 score on a scale
Interval 0.13 to 0.24
|
|
Mood Scores
Mean change at Year 1
|
0.03 score on a scale
Interval -0.01 to 0.07
|
0.03 score on a scale
Interval 0.0 to 0.07
|
0.05 score on a scale
Interval 0.01 to 0.09
|
0.01 score on a scale
Interval -0.02 to 0.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of randomization until the date of the occurrence of the endpoint, death, or the end of the trial, whichever came first, assessed up to a median of 5.3 years of follow-upPopulation: Post-hoc Outcome. Incident Depression is defined as depression cases that occurred among those with no past history of depression as of baseline. Incident depression event was determined by presence of clinical diagnosis, treatment and/or above-threshold symptoms on mood questionnaire (i.e., PHQ-8 \>=10 points). Among the n=18,353 participants randomized, there were n=16657 without a history of depression at baseline and therefore at risk for incident depression.
Post-hoc Outcome. Incident Depression is defined as depression cases that occurred among those with no past history of depression as of baseline. Incident depression event was determined by presence of clinical diagnosis, treatment and/or above-threshold symptoms on mood questionnaire (i.e., PHQ-8 \>=10 points).
Outcome measures
| Measure |
Active Vitamin D
n=8350 Participants
Vitamin D3: Vitamin D3 (cholecalciferol), one 2000 IU capsule per day
|
Vitamin D Placebo
n=8307 Participants
Vitamin D placebo: Vitamin D placebo, one capsule per day
|
Active Fish Oil
n=8322 Participants
Fish oil: Omacor, one 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 \[DHA\])
|
Fish Oil Placebo
n=8335 Participants
Fish oil placebo: Fish oil placebo, one capsule per day
|
|---|---|---|---|---|
|
Number of Participants With an Incident Depression Event
|
459 Participants
|
461 Participants
|
493 Participants
|
427 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of randomization until the date of the occurrence of the endpoint, death, or the end of the trial, whichever came first, assessed up to a median of 5.3 years of follow-upPopulation: Post-hoc Outcome. Recurrent Depression is defined as depression cases that occurred among those with past history of depression, but not active in the past 2 years as of baseline. Recurrent depression event will be determined by presence of clinical diagnosis, treatment and/or above-threshold symptoms on mood questionnaire (i.e., PHQ-8 \>=10 points). Among n=18,353 randomized, n=1696 were eligible for recurrent depression.
Post-hoc Outcome. Recurrent depression is defined as depression cases that occurred among those with past history of depression, but not under treatment or active in the past 2 years as of baseline. Recurrent depression event will be determined by presence of clinical diagnosis, treatment and/or above-threshold symptoms on mood questionnaire (i.e., PHQ-8 \>=10 points).
Outcome measures
| Measure |
Active Vitamin D
n=831 Participants
Vitamin D3: Vitamin D3 (cholecalciferol), one 2000 IU capsule per day
|
Vitamin D Placebo
n=865 Participants
Vitamin D placebo: Vitamin D placebo, one capsule per day
|
Active Fish Oil
n=849 Participants
Fish oil: Omacor, one 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 \[DHA\])
|
Fish Oil Placebo
n=847 Participants
Fish oil placebo: Fish oil placebo, one capsule per day
|
|---|---|---|---|---|
|
Number of Participants With a Recurrent Depression Event
|
150 Participants
|
164 Participants
|
158 Participants
|
156 Participants
|
Adverse Events
Vitamin D + Fish Oil
Serious events: 549 serious events
Other events: 2825 other events
Deaths: 153 deaths
Vitamin D + Fish Oil Placebo
Serious events: 545 serious events
Other events: 2803 other events
Deaths: 153 deaths
Vitamin D Placebo + Fish Oil
Serious events: 569 serious events
Other events: 2789 other events
Deaths: 152 deaths
Vitamin D Placebo + Fish Oil Placebo
Serious events: 570 serious events
Other events: 2876 other events
Deaths: 133 deaths
Serious adverse events
| Measure |
Vitamin D + Fish Oil
n=4608 participants at risk
Vitamin D: Vitamin D3 (cholecalciferol), 2000 IU per day
Fish oil: Omacor, one 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 + Fish Oil Placebo
n=4573 participants at risk
Vitamin D: Vitamin D3 (cholecalciferol), 2000 IU per day
Fish oil placebo: Fish oil placebo, one capsule per day
|
Vitamin D Placebo + Fish Oil
n=4563 participants at risk
Vitamin D placebo: Vitamin D3 placebo, one capsule per day
Fish oil: Omacor, one 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
n=4609 participants at risk
Vitamin D placebo: Vitamin D3 placebo, one capsule per day
Fish oil placebo: Fish oil placebo, one capsule per day
|
|---|---|---|---|---|
|
Vascular disorders
Major cardiovascular event
|
2.6%
120/4608 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
3.1%
144/4573 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
2.8%
129/4563 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
2.7%
126/4609 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive cancer of any type
|
6.8%
312/4608 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
6.1%
281/4573 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
6.6%
301/4563 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
6.3%
291/4609 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
|
Blood and lymphatic system disorders
Gastrointestinal Bleeding
|
2.3%
107/4608 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
2.4%
111/4573 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
2.9%
133/4563 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
2.9%
135/4609 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
|
Endocrine disorders
Hypercalcemia
|
0.91%
42/4608 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
1.0%
47/4573 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
1.1%
49/4563 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
1.1%
53/4609 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
|
Psychiatric disorders
Suicide
|
0.02%
1/4608 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
0.00%
0/4573 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
0.02%
1/4563 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
0.02%
1/4609 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
Other adverse events
| Measure |
Vitamin D + Fish Oil
n=4608 participants at risk
Vitamin D: Vitamin D3 (cholecalciferol), 2000 IU per day
Fish oil: Omacor, one 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 + Fish Oil Placebo
n=4573 participants at risk
Vitamin D: Vitamin D3 (cholecalciferol), 2000 IU per day
Fish oil placebo: Fish oil placebo, one capsule per day
|
Vitamin D Placebo + Fish Oil
n=4563 participants at risk
Vitamin D placebo: Vitamin D3 placebo, one capsule per day
Fish oil: Omacor, one 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
n=4609 participants at risk
Vitamin D placebo: Vitamin D3 placebo, one capsule per day
Fish oil placebo: Fish oil placebo, one capsule per day
|
|---|---|---|---|---|
|
Endocrine disorders
Hyperparathyroidism or parathyroid condition
|
0.22%
10/4608 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
0.42%
19/4573 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
0.37%
17/4563 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
0.59%
27/4609 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
|
Renal and urinary disorders
Kidney stones
|
3.4%
158/4608 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
3.8%
172/4573 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
2.9%
131/4563 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
3.5%
163/4609 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
|
Renal and urinary disorders
Kidney failure
|
0.41%
19/4608 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
0.59%
27/4573 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
0.61%
28/4563 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
0.63%
29/4609 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
|
Blood and lymphatic system disorders
Hematuria
|
7.2%
333/4608 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
7.0%
319/4573 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
6.4%
293/4563 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
6.9%
318/4609 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
|
Blood and lymphatic system disorders
Easy bruising
|
25.0%
1152/4608 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
25.5%
1167/4573 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
24.6%
1124/4563 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
24.8%
1141/4609 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
|
Blood and lymphatic system disorders
Frequent nosebleeds
|
3.5%
159/4608 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
3.5%
159/4573 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
3.5%
158/4563 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
3.5%
163/4609 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
|
Gastrointestinal disorders
Stomach upset or pain
|
35.0%
1615/4608 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
34.9%
1594/4573 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
35.4%
1616/4563 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
35.3%
1625/4609 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
24.4%
1124/4608 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
24.2%
1105/4573 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
25.6%
1169/4563 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
25.7%
1184/4609 • Adverse event data were collected over the entire randomized treatment and follow-up period, which was a median of 5.3 years. VITAL-DEP is an ancillary study of the VITAL trial. For total adverse events reported by the parent VITAL trial, please see Results reported by VITAL, NCT01169259.
Results for adverse events are reported by each of the 4 factorial arms of the trial.
|
Additional Information
Dr. Olivia Okereke/Study Principal Investigator
Massachusetts General Hospital
Phone: (617) 726-2000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place