Hypertension, Kidney Diseases
Conditions
Keywords
Hypertension, Kidney Diseases, Vitamin D, Omega 3 fatty acids
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTVitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day
DRUGOmega-3 Fatty acids
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_SUPPLEMENTVitamin D3 placebo
Vitamin D3 placebo
DIETARY_SUPPLEMENTFish oil placebo
Fish oil placebo
Sponsors
Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Parent (VITAL; NCT01169259) study was based upon a 2x2 factorial design
Eligibility
Sex/Gender
ALL
Age
50 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Participants in VITAL (NCT01169259) with a self-reported physician diagnosis of hypertension are eligible to participate in this ancillary study
Exclusion criteria
* Diagnosis of diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Estimated Glomerular Filtration Rate | Baseline and 4 years | Serum creatinine and cystatin C measurement pre-randomization and year 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confirmation of Microalbuminuria | 4 years post-randomization | Number of participants with positive Microalbuminuria was reported. Participants were defined as having positive microalbuminuria if their lab results were \>30 mg/g Creatinine |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 \[DHA\]). | 545 |
| 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) | 570 |
| 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 | 576 |
| 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 | 541 |
| Total | 2,232 |
Baseline characteristics
| Characteristic | Vitamin D and Omega-3 Fatty Acids | Total | Vitamin D Placebo and Omega-3 Fatty Acids Placebo | Vitamin D Placebo and Omega-3 Fatty Acids | Vitamin D and Omega-3 Fatty Acid Placebo |
|---|---|---|---|---|---|
| Age, Continuous | 68.5 years STANDARD_DEVIATION 6 | 68.7 years STANDARD_DEVIATION 6.2 | 68.3 years STANDARD_DEVIATION 6.1 | 69.0 years STANDARD_DEVIATION 6.2 | 69.0 years STANDARD_DEVIATION 6.4 |
| Creatinine | 0.89 mg/dL STANDARD_DEVIATION 0.23 | 0.89 mg/dL STANDARD_DEVIATION 0.26 | 0.87 mg/dL STANDARD_DEVIATION 0.22 | 0.90 mg/dL STANDARD_DEVIATION 0.35 | 0.89 mg/dL STANDARD_DEVIATION 0.24 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 3 Participants | 17 Participants | 5 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 5 Participants | 24 Participants | 9 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 15 Participants | 67 Participants | 16 Participants | 19 Participants | 17 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 58 Participants | 289 Participants | 73 Participants | 79 Participants | 79 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 438 Participants | 1736 Participants | 419 Participants | 442 Participants | 437 Participants |
| Race/Ethnicity, Customized Other | 12 Participants | 44 Participants | 8 Participants | 13 Participants | 11 Participants |
| Race/Ethnicity, Customized Unknown | 14 Participants | 55 Participants | 11 Participants | 15 Participants | 15 Participants |
| Region of Enrollment United States | 545 participants | 2232 participants | 541 participants | 576 participants | 570 participants |
| Sex: Female, Male Female | 278 Participants | 1175 Participants | 285 Participants | 303 Participants | 309 Participants |
| Sex: Female, Male Male | 267 Participants | 1057 Participants | 256 Participants | 273 Participants | 261 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 545 | 0 / 570 | 0 / 576 | 0 / 541 |
| other Total, other adverse events | 4 / 545 | 6 / 570 | 6 / 576 | 6 / 541 |
| serious Total, serious adverse events | 0 / 545 | 0 / 570 | 0 / 576 | 0 / 541 |
Outcome results
Primary
Change in Estimated Glomerular Filtration Rate
Serum creatinine and cystatin C measurement pre-randomization and year 4
Time frame: Baseline and 4 years
Population: Glomerular filtration rate data was not collected as samples were never analyzed.
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
Time frame: 4 years post-randomization
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vitamin D and Omega-3 Fatty Acids | Confirmation of Microalbuminuria | 4 Participants |
| Vitamin D and Omega-3 Fatty Acid Placebo | Confirmation of Microalbuminuria | 6 Participants |
| Vitamin D Placebo and Omega-3 Fatty Acids | Confirmation of Microalbuminuria | 6 Participants |
| Vitamin D Placebo and Omega-3 Fatty Acids Placebo | Confirmation of Microalbuminuria | 6 Participants |