Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 2,232
- Locations
- 1
- Primary Endpoint
- Change in Estimated Glomerular Filtration Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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]).
Intervention: Vitamin D3 (Dietary Supplement)
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]).
Intervention: Omega-3 Fatty acids (Drug)
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)
Intervention: Vitamin D3 (Dietary Supplement)
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)
Intervention: Fish oil placebo (Dietary Supplement)
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
Intervention: Omega-3 Fatty acids (Drug)
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
Intervention: Vitamin D3 placebo (Dietary Supplement)
Vitamin D Placebo and Omega-3 Fatty acid 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
Intervention: Vitamin D3 placebo (Dietary Supplement)
Vitamin D Placebo and Omega-3 Fatty acid 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
Intervention: Fish oil placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Change in Estimated Glomerular Filtration Rate
Time Frame: Baseline and 4 years
Serum creatinine and cystatin C measurement pre-randomization and year 4
Secondary Outcomes
- Confirmation of Microalbuminuria(4 years post-randomization)