@article {1359925,
	title = {Vitamin D and omega-3 trial to prevent and treat diabetic kidney disease: Rationale, design, and baseline characteristics},
	journal = {Contemp Clin Trials},
	volume = {74},
	year = {2018},
	month = {2018 Nov},
	pages = {11-17},
	abstract = {Diabetic kidney disease (DKD), defined as reduced glomerular filtration rate (GFR), elevated urine albumin excretion, or both that is clinically attributable to diabetes, is a common and morbid diabetes complication. Animal-experimental data, observational human studies, and short-term clinical trials suggest that vitamin D and omega-3 fatty acid supplements may be safe and inexpensive interventions to reduce the incidence and progression of DKD. The Vitamin D and Omega-3 Trial to Prevent and Treat DKD (VITAL-DKD) was designed as an ancillary study to the VITAL trial of 25,871 US adults. In a 2 {\texttimes} 2 factorial design, VITAL participants were randomly assigned to vitamin D (cholecalciferol, 2000 IU daily) or placebo and to marine omega-3 fatty acids (eicospentaenoic acid and docosahexaenoic acid, 1 g/d) or placebo. VITAL-DKD enrolled a subset of 1326 VITAL participants with type 2 diabetes at baseline to test the effects of vitamin D and omega-3 fatty acids on changes in estimated GFR and urine albumin excretion. Over five years of follow-up, VITAL-DKD collected blood and urine samples to quantify changes in estimated GFR (the primary study outcome) and urine albumin excretion. At baseline, mean age of VITAL-DKD participants was 67.6 years, 46\% were women, 30\% were of racial or ethnic minority, and the prevalence of DKD (estimated GFR \&lt;60 mL/min/1.73m or urine albumin-creatinine ratio >= 30 mg/g) was 17\%. In this type 2 diabetes population, VITAL-DKD will test the hypotheses that vitamin D and omega-3 fatty acids help prevent the development and progression of DKD.},
	issn = {1559-2030},
	doi = {10.1016/j.cct.2018.09.014},
	author = {de Boer, Ian H and Zelnick, Leila R and Lin, Julie and Schaumberg, Debra and Wang, Lu and Ruzinski, John and Friedenberg, Georgina and Duszlak, Julie and Bubes, Vadim Y and Hoofnagle, Andrew N and Thadhani, Ravi and Glynn, Robert J and Buring, Julie E and Sesso, Howard D and Manson, JoAnn E}
}
