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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Ian deBoer, University of Washington
ClinicalTrials.gov Identifier:
NCT01684722
First received: September 6, 2012
Last updated: April 9, 2014
Last verified: April 2014

September 6, 2012
April 9, 2014
July 2010
June 2016   (final data collection date for primary outcome measure)
Change in urine albumin excretion [ Time Frame: baseline and 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01684722 on ClinicalTrials.gov Archive Site
  • Change in estimated glomerular filtration rate [ Time Frame: baseline and 3 years ] [ Designated as safety issue: No ]
  • Change in glycemic control [ Time Frame: baseline and 3 years ] [ Designated as safety issue: No ]
  • Change in C-reactive protein [ Time Frame: baseline and 3 years ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: baseline and 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vitamin D and Omega-3 Trial to Prevent and Treat Diabetic Kidney Disease
Vitamin D and Omega-3 Trial to Prevent and Treat Diabetic Kidney Disease

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Diabetes
  • 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 D placebo
    Vitamin D3 placebo
  • Dietary Supplement: Fish oil placebo
    Fish oil placebo
  • Active Comparator: Vitamin D + fish oil
    Vitamin D and omega-3 fatty acids (fish oil)
    Interventions:
    • Dietary Supplement: Vitamin D
    • Drug: Omega-3 fatty acids (fish oil)
  • Active Comparator: Vitamin D + fish oil placebo
    Vitamin D and fish oil placebo
    Interventions:
    • Dietary Supplement: Vitamin D
    • Dietary Supplement: Fish oil placebo
  • Active Comparator: Vitamin D placebo + fish oil
    Vitamin D placebo and omega-3 fatty acids (fish oil)
    Interventions:
    • Drug: Omega-3 fatty acids (fish oil)
    • Dietary Supplement: Vitamin D placebo
  • Placebo Comparator: Vitamin D placebo + fish oil placebo
    Vitamin D placebo and fish oil placebo
    Interventions:
    • Dietary Supplement: Vitamin D placebo
    • Dietary Supplement: Fish oil placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1320
Not Provided
June 2016   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01684722
39113-EA, R01DK088762
Yes
Ian deBoer, University of Washington
University of Washington
  • Brigham and Women's Hospital
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Ian H de Boer, MD, MS University of Washington
University of Washington
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP