Overview

This trial is active, not recruiting.

Condition diabetes
Treatments vitamin d, omega-3 fatty acids (fish oil), vitamin d placebo, fish oil placebo
Sponsor University of Washington
Collaborator Brigham and Women's Hospital
Start date July 2010
End date December 2017
Trial size 1320 participants
Trial identifier NCT01684722, 39113-EA, R01DK088762

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Vitamin D and omega-3 fatty acids (fish oil)
vitamin d
Vitamin D3 (cholecalciferol), 2000 IU per day.
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 and fish oil placebo
vitamin d
Vitamin D3 (cholecalciferol), 2000 IU per day.
fish oil placebo
Fish oil placebo
(Active Comparator)
Vitamin D placebo and omega-3 fatty acids (fish oil)
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]).
vitamin d placebo
Vitamin D3 placebo
(Placebo Comparator)
Vitamin D placebo and fish oil placebo
vitamin d placebo
Vitamin D3 placebo
fish oil placebo
Fish oil placebo

Primary Outcomes

Measure
Change in urine albumin excretion
time frame: baseline and 3 years

Secondary Outcomes

Measure
Change in estimated glomerular filtration rate
time frame: baseline and 3 years
Change in glycemic control
time frame: baseline and 3 years
Change in C-reactive protein
time frame: baseline and 3 years
Change in blood pressure
time frame: baseline and 3 years

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title Vitamin D and Omega-3 Trial to Prevent and Treat Diabetic Kidney Disease
Principal investigator Ian H de Boer, MD, MS
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Washington.