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

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

Sponsors

Lead Sponsor: Albert Einstein College of Medicine

Collaborator: Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Source Albert Einstein College of Medicine
Brief Summary

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) 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.

Overall Status Active, not recruiting
Start Date 2016-04-01
Completion Date 2021-11-01
Primary Completion Date 2021-09-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in estimated glomerular filtration rate 4 years
Secondary Outcome
Measure Time Frame
Prevalence of Albuminuria 4 years post-randomization
Enrollment 2612
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Vitamin D3

Description: Vitamin D3 (cholecalciferol), 2000 IU per day

Intervention Type: Drug

Intervention Name: Omega-3 Fatty acids

Description: 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])

Other Name: Fish oil

Intervention Type: Dietary Supplement

Intervention Name: Vitamin D3 placebo

Description: Vitamin D3 placebo

Intervention Type: Dietary Supplement

Intervention Name: Fish oil placebo

Description: Fish oil placebo

Eligibility

Criteria:

Inclusion Criteria: - Participants in VITAL (NCT 01169259) with a self-reported physician diagnosis of hypertension are eligible to participate in this ancillary study Exclusion Criteria: - Diagnosis of diabetes mellitus

Gender:

All

Minimum Age:

50 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Michal L Melamed, MD, MHS Principal Investigator Albert Einstein College of Medicine
Location
Facility: Brigham and Women's Hospital
Location Countries

United States

Verification Date

2021-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Vitamin D and fish oil

Type: Active Comparator

Description: Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), 2000 IU 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]).

Label: Vitamin D and fish oil placebo

Type: Active Comparator

Description: Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), 2000 IU per day. Dietary Supplement: Fish oil placebo Fish oil placebo

Label: Vitamin D placebo and fish oil

Type: Active Comparator

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 Vitamin D3 placebo

Label: Vitamin D placebo and fish oil placebo

Type: Placebo Comparator

Description: Dietary Supplement: Vitamin D placebo Vitamin D3 placebo Dietary Supplement: Fish oil placebo Fish oil placebo

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Investigator, Outcomes Assessor)

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