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

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ClinicalTrials.gov Identifier: NCT02757872
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : April 22, 2022
Sponsor:
Collaborators:
Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertension Kidney Diseases Dietary Supplement: Vitamin D3 Drug: Omega-3 Fatty acids Dietary Supplement: Vitamin D3 placebo Dietary Supplement: Fish oil placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2612 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives
Actual Study Start Date : April 2016
Actual Primary Completion Date : March 31, 2022
Actual Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Active Comparator: Vitamin D and fish oil
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]).
Dietary Supplement: Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day

Drug: Omega-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])
Other Name: Fish oil

Active Comparator: Vitamin D and fish oil placebo
Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), 2000 IU per day. Dietary Supplement: Fish oil placebo Fish oil placebo
Dietary Supplement: Vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day

Dietary Supplement: Fish oil placebo
Fish oil placebo

Active Comparator: Vitamin D placebo and fish oil

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

Drug: Omega-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])
Other Name: Fish oil

Dietary Supplement: Vitamin D3 placebo
Vitamin D3 placebo

Placebo Comparator: Vitamin D placebo and fish oil placebo
Dietary Supplement: Vitamin D placebo Vitamin D3 placebo Dietary Supplement: Fish oil placebo Fish oil placebo
Dietary Supplement: Vitamin D3 placebo
Vitamin D3 placebo

Dietary Supplement: Fish oil placebo
Fish oil placebo




Primary Outcome Measures :
  1. Change in estimated glomerular filtration rate [ Time Frame: 4 years ]
    Serum creatinine and cystatin C measurement pre-randomization and year 4


Secondary Outcome Measures :
  1. Prevalence of Albuminuria [ Time Frame: 4 years post-randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757872


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Albert Einstein College of Medicine
Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Michal L Melamed, MD, MHS Albert Einstein College of Medicine
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Responsible Party: Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT02757872    
Other Study ID Numbers: 2014-3778
R01DK102952 ( U.S. NIH Grant/Contract )
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022
Keywords provided by Albert Einstein College of Medicine:
Hypertension
Kidney Diseases
Vitamin D
Omega 3 fatty acids
Additional relevant MeSH terms:
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Kidney Diseases
Hypertension
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents