Vitamin D and Omega-3 Trial to Prevent and Treat Diabetic Kidney Disease (VITAL-DKD)

June 15, 2022 updated by: Ian deBoer, University of Washington
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL with a history of diabetes and will examine whether vitamin D or fish oil prevents the development and progression of diabetic kidney disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 diabetic kidney disease (DKD). Persons with diabetes are at high risk of kidney disease. In 2005-2008, the prevalence of DKD among people with type 2 diabetes in the United States was 34.5%. Moreover, from 1988-1994 to 2005-2008, the prevalence of DKD in the United States grew 34% to 6.9 million people. DKD is both the leading cause of end stage renal disease in the developed world and a potent amplifier of cardiovascular disease risk.

Vitamin D and omega-3 fatty acids are promising interventions for DKD 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 DKD in large populations. This VITAL ancillary study will test whether vitamin D3 and/or omega-3 fatty acids prevent progression of albuminuria and loss of glomerular filtration rate, two complementary manifestations of DKD, over 3 years of treatment.

In VITAL, 20,000 participants will be 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 diabetes at baseline and ascertain effects of study interventions on albuminuria and glomerular filtration rate in this group. First morning voids will be collected at baseline and year 3 for measurement of urine albumin-creatinine ratio. Blood samples will be collected 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 DKD.

Study Type

Interventional

Enrollment (Actual)

1312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

  • Type 1 diabetes
  • Diabetes only during pregnancy
  • Known cause of kidney disease other than diabetes
  • History of kidney transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Vitamin D + fish oil
Vitamin D and omega-3 fatty acids (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
Vitamin D3 (cholecalciferol), 2000 IU per day.
ACTIVE_COMPARATOR: Vitamin D + fish oil placebo
Vitamin D and fish oil placebo
Dietary supplement: Fish oil placebo
Fish oil placebo
Dietary supplement: Vitamin D
Vitamin D3 (cholecalciferol), 2000 IU per day.
ACTIVE_COMPARATOR: Vitamin D placebo + fish oil
Vitamin D placebo and omega-3 fatty acids (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
PLACEBO_COMPARATOR: Vitamin D placebo + fish oil placebo
Vitamin D placebo and fish oil placebo
Dietary supplement: Fish oil placebo
Fish oil placebo
Dietary supplement: Vitamin D placebo
Vitamin D3 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Estimated Glomerular Filtration Rate
Time Frame: baseline to 5 years
GFR estimated from serum creatinine and cystatin C
baseline to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Urine Albumin Excretion
Time Frame: baseline to 5 years
Change in urine albumin-creatinine ratio.
baseline to 5 years
Change in C-reactive Protein
Time Frame: baseline to 5 years
Changes in serum concentrations in CRP
baseline to 5 years
Change in Interleukin-6
Time Frame: baseline to 5 years
Changes in serum concentrations in IL-6
baseline to 5 years
Change in NT-proBNP
Time Frame: baseline to 5 years
Changes in serum concentrations in NT-proBNP
baseline to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2010

Primary Completion (ACTUAL)

November 8, 2019

Study Completion (ACTUAL)

November 8, 2019

Study Registration Dates

First Submitted

September 6, 2012

First Submitted That Met QC Criteria

September 10, 2012

First Posted (ESTIMATE)

September 13, 2012

Study Record Updates

Last Update Posted (ACTUAL)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 15, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39113
  • R01DK088762 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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