Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives

Phase 3

Completed

Conditions: Kidney Diseases
Hypertension

Interventions: Dietary Supplement: Vitamin D3
Dietary Supplement: Fish oil placebo
Dietary Supplement: Vitamin D3 placebo
Drug: Omega-3 Fatty acids

Registration Number: NCT02757872

Lead Sponsor: Albert Einstein College of Medicine

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2232

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Vitamin D and Omega-3 Fatty acids	Vitamin D3	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	Vitamin D3	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 and Omega-3 Fatty acid Placebo	Fish oil placebo	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	Vitamin D3 placebo	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	Vitamin D3 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
Vitamin D Placebo and Omega-3 Fatty acid Placebo	Fish oil 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
Vitamin D and Omega-3 Fatty acids	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 \[DHA\]).
Vitamin D Placebo and Omega-3 Fatty acids	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

Primary Outcome Measures

Name	Time	Method
Change in Estimated Glomerular Filtration Rate	Baseline and 4 years	Serum creatinine and cystatin C measurement pre-randomization and year 4

Secondary Outcome Measures

Name	Time	Method
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