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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK102952 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The VITamin D and OmegA-3 TriaL (VITAL; NCT01169259) is an ongoing randomized clinical trial in 25,875 US men and women investigating whether taking dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor (R) 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. The VITAL Kidney Function in Hypertension ancillary study will evaluate the effects of vitamin D or omega-3 fatty acids on kidney function among participants with baseline hypertension.
This ancillary study to the VITamin D and OmegA-3 TriaL (VITAL) will test whether vitamin D3, omega-3 fatty acids, or both prevent the development and progression of kidney disease in participants with hypertension. Persons with hypertension are at high risk of kidney disease.
Vitamin D and omega-3 fatty acids are promising interventions for kidney disease prevention and treatment, based on results of animal-experimental models and early human studies. Because these interventions are relatively safe, inexpensive, and widely available, they may offer opportunity to substantially reduce the burden of kidney disease in large populations. This VITAL ancillary study will test whether vitamin D3 and/or omega-3 fatty acids prevent loss of glomerular filtration rate, over 4 years of therapy.
In VITAL, 25,875 participants have been randomly assigned in a 2x2 factorial design to vitamin D3 (cholecalciferol) 2000 IU daily versus placebo, and to eicosapentaenoic acid 465 mg plus docosahexaenoic acid 375 mg daily versus placebo, and followed for a mean of 5 years to assess effects on cardiovascular disease and cancer events. This ancillary study will identify and recruit a sub-cohort of VITAL participants with hypertension at baseline and ascertain effects of study interventions on glomerular filtration rate in this group. Blood samples will be collected at year 4 simultaneously for measurement of estimated glomerular filtration rate (using serum creatinine and cystatin C) and other relevant biomarkers. This VITAL ancillary study is designed to determine whether vitamin D3 and/or omega-3 fatty acids have causal and clinically relevant effects on the development and progression of kidney disease in hypertensives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D and Omega-3 Fatty acids | Active Comparator | Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day. Drug: 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 and Omega-3 Fatty acid Placebo | Active Comparator | Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day. Dietary Supplement: Omega-3 fatty acid placebo (Fish oil placebo) |
|
| Vitamin D Placebo and Omega-3 Fatty acids | Active Comparator | Drug: 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]). Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo |
|
| Vitamin D Placebo and Omega-3 Fatty acid Placebo | Placebo Comparator | Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo Dietary Supplement: Omega-3 Fatty acid Placebo (Fish oil placebo). One capsule per 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 Estimated Glomerular Filtration Rate | Serum creatinine and cystatin C measurement pre-randomization and year 4 | Baseline and 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmation of Microalbuminuria | Number of participants with positive Microalbuminuria was reported. Participants were defined as having positive microalbuminuria if their lab results were >30 mg/g Creatinine | 4 years post-randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michal L Melamed, MD, MHS | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D and Omega-3 Fatty Acids | Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day. Drug: 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]). |
| FG001 | Vitamin D and Omega-3 Fatty Acid Placebo | Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day. Dietary Supplement: Omega-3 fatty acid placebo (Fish oil placebo) |
| FG002 | Vitamin D Placebo and Omega-3 Fatty Acids | Drug: 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]). Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo |
| FG003 | Vitamin D Placebo and Omega-3 Fatty Acids Placebo | Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo Dietary Supplement: Omega-3 Fatty acid Placebo (Fish oil placebo). One capsule per day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D and Omega-3 Fatty Acids | Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day. Drug: 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]). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Estimated Glomerular Filtration Rate | Serum creatinine and cystatin C measurement pre-randomization and year 4 | Glomerular filtration rate data was not collected as samples were never analyzed. | Posted | Baseline and 4 years |
|
4 years
This ancillary study is not administering any treatments. All treatment monitoring occurred through the parent VITAL study (NCT01169259). The only adverse events obtained were in conjunction with results from laboratory samples collected for analysis at ~4 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 | Vitamin D and Omega-3 Fatty Acids | Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day. Drug: 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]). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Microalbuminuria | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michal Melamed | NYU Langone | 212-263-0705 | michal.melamed@nyulangone.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 10, 2018 | May 29, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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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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Parent (VITAL; NCT01169259) study was based upon a 2x2 factorial design
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| Omega-3 Fatty acids | 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 D3 placebo |
|
| Fish oil placebo | Dietary Supplement | Fish oil placebo |
|
| BG001 |
| Vitamin D and Omega-3 Fatty Acid Placebo |
Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day. Dietary Supplement: Omega-3 fatty acid placebo (Fish oil placebo) |
| BG002 | Vitamin D Placebo and Omega-3 Fatty Acids | Drug: 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]). Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo |
| BG003 | Vitamin D Placebo and Omega-3 Fatty Acids Placebo | Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo Dietary Supplement: Omega-3 Fatty acid Placebo (Fish oil placebo). One capsule per day |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Creatinine | Mean | Standard Deviation | mg/dL |
|
Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day.
Dietary Supplement: Omega-3 fatty acid placebo (Fish oil placebo)
| OG002 | Vitamin D Placebo and Omega-3 Fatty Acids | Drug: 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]). Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo |
| OG003 | Vitamin D Placebo and Omega-3 Fatty Acids Placebo | Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo Dietary Supplement: Omega-3 Fatty acid Placebo (Fish oil placebo). One capsule per day |
|
| Secondary | Confirmation of Microalbuminuria | Number of participants with positive Microalbuminuria was reported. Participants were defined as having positive microalbuminuria if their lab results were >30 mg/g Creatinine | Urine samples were not collected from 34 participants in the 'Vitamin D and Fish Oil' group; 41 participants in the 'Vitamin D and Fish Oil Placebo' group; 33 participants in the 'Vitamin D Placebo and Fish Oil' group; and 35 participants in the 'Vitamin D Placebo and Fish Oil Placebo' group. As such, there was no data to analyze from these participants. | Posted | Count of Participants | Participants | 4 years post-randomization |
|
|
|
| 0 |
| 545 |
| 0 |
| 545 |
| 4 |
| 545 |
| EG001 | Vitamin D and Omega-3 Fatty Acid Placebo | Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day. Dietary Supplement: Omega-3 fatty acid placebo (Fish oil placebo) | 0 | 570 | 0 | 570 | 6 | 570 |
| EG002 | Vitamin D Placebo and Omega-3 Fatty Acids | Drug: 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]). Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo | 0 | 576 | 0 | 576 | 6 | 576 |
| EG003 | Vitamin D Placebo and Omega-3 Fatty Acids Placebo | Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo Dietary Supplement: Omega-3 Fatty acid Placebo (Fish oil placebo). One capsule per day | 0 | 541 | 0 | 541 | 6 | 541 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| 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 |