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

Albert Einstein College of Medicine

Status and phase: Completed; Phase 3

Conditions: Hypertension; Kidney Diseases

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02757872

2014-3778

R01DK102952 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,232 patients

Sex: All

Ages: 50 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

---

2,232 participants in 4 patient groups, including a placebo group

Vitamin D and Omega-3 Fatty acids

Active Comparator group

Description:

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 \[DHA\]).

Treatment:

Dietary Supplement: Vitamin D3

Drug: Omega-3 Fatty acids

Vitamin D and Omega-3 Fatty acid Placebo

Active Comparator group

Description:

Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day. Dietary Supplement: Omega-3 fatty acid placebo (Fish oil placebo)

Treatment:

Dietary Supplement: Vitamin D3

Dietary Supplement: Fish oil placebo

Vitamin D Placebo and Omega-3 Fatty acids

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Vitamin D3 placebo

Drug: Omega-3 Fatty acids

Vitamin D Placebo and Omega-3 Fatty acid Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Vitamin D3 placebo

Dietary Supplement: Fish oil placebo