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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01684722
Recruitment Status : Active, not recruiting
First Posted : September 13, 2012
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ian deBoer, University of Washington

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Dietary Supplement: Vitamin D Drug: Omega-3 fatty acids (fish oil) Dietary Supplement: Vitamin D placebo Dietary Supplement: Fish oil placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1326 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D and Omega-3 Trial to Prevent and Treat Diabetic Kidney Disease
Actual Study Start Date : July 2010
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Vitamin D + fish oil
Vitamin D and omega-3 fatty acids (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]).

Active Comparator: Vitamin D + fish oil placebo
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

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: Vitamin D placebo
Vitamin D3 placebo

Dietary Supplement: Fish oil placebo
Fish oil placebo




Primary Outcome Measures :
  1. Change in estimated glomerular filtration rate [ Time Frame: baseline, 2 years, and 5 years ]
    GFR estimated from serum creatinine and cystatin C


Secondary Outcome Measures :
  1. Change in urine albumin excretion [ Time Frame: baseline, 2 years, and 5 years ]
    Urine albumin-creatinine ratio

  2. Change in glycemic control [ Time Frame: baseline and 2 years ]
    Hemoglobin A1c

  3. Change in C-reactive protein [ Time Frame: baseline, 2 years, and 5 years ]
  4. Change in blood pressure [ Time Frame: baseline, 2 years, and 5 years ]
  5. Change in interleukin-6 [ Time Frame: baseline, 2 years, and 5 years ]
  6. Change in NT-proBNP [ Time Frame: baseline, 2 years, and 5 years ]


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 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

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): NCT01684722


Locations
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United States, Massachusetts
Brigham Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
University of Washington
Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Ian H de Boer, MD, MS University of Washington

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ian deBoer, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01684722    
Other Study ID Numbers: 39113
R01DK088762 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Keywords provided by Ian deBoer, University of Washington:
vitamin D3
omega-3 fatty acids
fish oil
diabetes
kidney disease
albuminuria
urine albumin excretion
glomerular filtration rate
diabetic kidney disease
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents