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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG036755 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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 fish oil is associated with cognitive decline in 3000 older participants of VITAL.
Primary aim of annual rate of cognitive decline. Secondary aims will be addressed in sub-set of participants: 1) among participants, African-American race (African-Americans have high risk of Vitamin D deficiency) modifies effects of vitamin D3 supplementation on cognitive decline; 2) among a subset of participants, baseline plasma levels of vitamin D and omega-3 fatty acids modify agent effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids | Active Comparator | 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 + PLACEBO Omega-3 Fatty Acids | Active Comparator | ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day |
|
| PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids | Active Comparator | 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 + PLACEBO Omega-3 Fatty Acids | Placebo Comparator | PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D3 | Dietary Supplement | Vitamin D3 (cholecalciferol), 2000 IU per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Global Composite Score for Cognitive Decline | We administered by telephone, eight cognitive tests (1.Telephone Interview of Cognitive Status (TICS); 2.Delayed recall of the TICS 10-word list; 3.East Boston Memory Test (EBMT); 4.Delayed recall of the EBMT; 5.Category fluency test (animal naming test); 6.Oral Trail Making Test (OTMT-Part A); 7. OTMT-Part B; 8.Digit span backwards). The primary endpoint was the change over time (last assessment score minus the baseline assessment score) in GLOBAL COMPOSITE SCORE (average of Z-scores of component tests); for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.004. | Change over two assessments (baseline, 2.8 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Episodic Memory Score for Cognitive Decline | The outcome measure was change over time (last assessment score minus the baseline assessment score) in the EPISODIC MEMORY SCORE combining z-scores of 4 tests: the immediate and delayed recalls of both the East Boston Memory Test (EBMT) and the Telephone Interview of Cognitive Status (TICS) 10-word list; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.01. |
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Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34853363 | Derived | Kang JH, Vyas CM, Okereke OI, Ogata S, Albert M, Lee IM, D'Agostino D, Buring JE, Cook NR, Grodstein F, Manson JE. Effect of vitamin D on cognitive decline: results from two ancillary studies of the VITAL randomized trial. Sci Rep. 2021 Dec 1;11(1):23253. doi: 10.1038/s41598-021-02485-8. |
| Label | URL |
|---|---|
| VITAL study website link | View source |
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In this telephone interview ancillary study, participants (NCT01169259) who:1) were aged 60 or more; 2) had no hearing impairment; 3) were willing to participate in a cognitive sub-study (during run-in phase) were included.
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| ID | Title | Description |
|---|---|---|
| FG000 | TELEPHONE INTERVIEW ANCILLARY STUDY: 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 | TELEPHONE INTERVIEW ANCILLARY STUDY: 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 | TELEPHONE INTERVIEW ANCILLARY STUDY: 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 | TELEPHONE INTERVIEW ANCILLARY STUDY: 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 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TELEPHONE INTERVIEW ANCILLARY STUDY: 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]). |
| 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 | Change in Global Composite Score for Cognitive Decline | We administered by telephone, eight cognitive tests (1.Telephone Interview of Cognitive Status (TICS); 2.Delayed recall of the TICS 10-word list; 3.East Boston Memory Test (EBMT); 4.Delayed recall of the EBMT; 5.Category fluency test (animal naming test); 6.Oral Trail Making Test (OTMT-Part A); 7. OTMT-Part B; 8.Digit span backwards). The primary endpoint was the change over time (last assessment score minus the baseline assessment score) in GLOBAL COMPOSITE SCORE (average of Z-scores of component tests); for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.004. | Posted | Mean | Standard Error | Z-score | Change over two assessments (baseline, 2.8 years). |
|
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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 | TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D | Vitamin D3, one 2000 IU capsule/day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment | Death |
| 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 | |
|---|---|---|---|---|
| Jae Hee Kang | Brigham and Women's Hospital;181 Longwood Ave; Boston, MA 02115 | 617-525-2022 | nhjhk@channing.harvard.edu |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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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 |
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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 | Vitamin D placebo |
|
| Fish oil placebo | Dietary Supplement | Fish oil placebo |
|
| Change over two assessments (baseline, 2.8 years) |
| Change in Executive Function Score for Cognitive Decline | The outcome measure is change over time (last assessment score minus the baseline assessment score) in the EXECUTIVE FUNCTION SCORE combining z-scores of 4 tests: category fluency (animal naming), digit span backwards, and Oral Trails Making Test (OTMT)-Part A and OTMT-Part B; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of +0.006. | Change over two assessments (baseline, 2.8 years) |
| Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline. | Change over time (last assessment score minus the baseline assessment score) on the TICS (0-41 points), a measure of general cognition. A higher value on the TICS represents better cognitive performance; for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.05 | Change over two assessments (baseline, 2.8 years) |
| BG001 |
| TELEPHONE INTERVIEW ANCILLARY STUDY: 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 | TELEPHONE INTERVIEW ANCILLARY STUDY: 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 | TELEPHONE INTERVIEW ANCILLARY STUDY: 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 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D | Vitamin D3, one 2000 IU capsule/day |
| OG001 | TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo | Vitamin D placebo, one capsule/day |
| OG002 | TELEPHONE INTERVIEW ANCILLARY STUDY: 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 | TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo | Omega-3 fatty acids placebo, one capsule/day |
|
|
|
| Secondary | Change in Episodic Memory Score for Cognitive Decline | The outcome measure was change over time (last assessment score minus the baseline assessment score) in the EPISODIC MEMORY SCORE combining z-scores of 4 tests: the immediate and delayed recalls of both the East Boston Memory Test (EBMT) and the Telephone Interview of Cognitive Status (TICS) 10-word list; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.01. | Posted | Mean | Standard Error | Z-score | Change over two assessments (baseline, 2.8 years) |
|
|
|
|
| Secondary | Change in Executive Function Score for Cognitive Decline | The outcome measure is change over time (last assessment score minus the baseline assessment score) in the EXECUTIVE FUNCTION SCORE combining z-scores of 4 tests: category fluency (animal naming), digit span backwards, and Oral Trails Making Test (OTMT)-Part A and OTMT-Part B; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of +0.006. | Posted | Mean | Standard Error | Z-score | Change over two assessments (baseline, 2.8 years) |
|
|
|
|
| Secondary | Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline. | Change over time (last assessment score minus the baseline assessment score) on the TICS (0-41 points), a measure of general cognition. A higher value on the TICS represents better cognitive performance; for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.05 | Posted | Mean | Standard Error | score on a scale | Change over two assessments (baseline, 2.8 years) |
|
|
|
|
| 41 |
| 1,710 |
| 138 |
| 1,710 |
| 1,259 |
| 1,710 |
| EG001 | TELEPHONE INTERVIEW ANCILLARY STUDY: Vitamin D Placebo | Vitamin D placebo, one capsule/day | 26 | 1,714 | 117 | 1,714 | 1,236 | 1,714 |
| EG002 | TELEPHONE INTERVIEW ANCILLARY STUDY: 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). | 42 | 1,699 | 134 | 1,699 | 1,220 | 1,699 |
| EG003 | TELEPHONE INTERVIEW ANCILLARY STUDY: Omega-3 Fatty Acids Placebo | Omega-3 fatty acids placebo, one capsule/day | 25 | 1,725 | 121 | 1,725 | 1,275 | 1,725 |
| EG004 | TELEPHONE INTERVIEW ANCILLARY STUDY: 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). | 26 | 844 | 74 | 844 | 600 | 844 |
| EG005 | TELEPHONE INTERVIEW ANCILLARY STUDY: Active Vitamin D/Placebo Omega-3 Fatty Acids | Vitamin D3, one 2000 IU capsule/day + Omega-3 fatty acids placebo, one capsule/day | 15 | 866 | 64 | 866 | 659 | 866 |
| EG006 | TELEPHONE INTERVIEW ANCILLARY STUDY: 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). | 16 | 855 | 60 | 855 | 620 | 855 |
| EG007 | TELEPHONE INTERVIEW ANCILLARY STUDY: Placebo Vitamin D/Placebo Omega-3 Fatty Acids | Vitamin D placebo, one capsule/day + Omega-3 fatty acids placebo, one capsule/day | 10 | 859 | 57 | 859 | 616 | 859 |
| Cancer | General disorders | Systematic Assessment | Cancer |
|
| Gastrointestinal bleeding | Gastrointestinal disorders | Systematic Assessment | Gastrointestinal bleeding |
|
| Hypercalcemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Major cardiovascular event | Cardiac 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 |
|
| Stomach upset of 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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| 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 |
| The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization). | Mixed Models Analysis | 0.03 | Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167). | Mean Difference (Net) | -0.02 | 2-Sided | 95 | -0.04 | -0.002 | Superiority |
| The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included terms for the variables time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization) | Mixed Models Analysis | 0.68 | Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167). | Mean Difference (Net) | 0.003 | 2-Sided | 95 | -0.01 | 0.02 | Superiority |
| The rates of cognitive decline over 2.8 years were compared in the two groups (rate in omega-3 active group minus the rate in placebo group). A mixed model included the variables, time since randomization, assignment to one arm, assignment to the other arm, sex, age, race/ethnicity, history of depression and the six interaction terms (products with time since randomization). | Mixed Models Analysis | 0.003 | Given the 3 secondary analyses, the p-value threshold was 0.0167 (=Bonferroni correction of 0.05/3=0.0167). | Mean Difference (Net) | -0.10 | 2-Sided | 95 | -0.17 | -0.04 | Superiority |