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Contemp Clin Trials. 2018 Nov;74:11-17. doi: 10.1016/j.cct.2018.09.014. Epub 2018 Sep 30.

Vitamin D and omega-3 trial to prevent and treat diabetic kidney disease: Rationale, design, and baseline characteristics.

Author information

1
Division of Nephrology and Kidney Research Institute, University of Washington, Seattle, WA, United States. Electronic address: deboer@u.washington.edu.
2
Division of Nephrology and Kidney Research Institute, University of Washington, Seattle, WA, United States.
3
Renal Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.
4
Real World Evidence, Evidera, PPD, Waltham MA, Department of Epidemiology, Harvard TH Chan School of Public Health, Department of Ophthalmology & Visual Sciences, University of Utah School of Medicine, Boston, MA, United States.
5
Department of Global Epidemiology, Janssen Research & Development LLC, Titusville, NJ, United States.
6
Kidney Research Institute, University of Washington, Seattle, WA, United States.
7
Division of Preventive Medicine, Brigham and Women's Hospital, MA, USA.
8
Department of Laboratory Medicine and Kidney Research Institute, University of Washington, Seattle, WA, United States.
9
Cedars-Sinai Medical Center, Los Angeles, CA, United States.
10
Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Harvard T.H. Chan School of Public Health, Boston, MA, United States.

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 × 2 factorial design, VITAL participants were randomly assigned to vitamin D3 (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 <60 mL/min/1.73m2 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.

KEYWORDS:

Chronic kidney disease; Diabetes; Diabetic kidney disease; Omega-3 fatty acids; Vitamin D

PMID:
30282055
PMCID:
PMC6203639
[Available on 2019-11-01]
DOI:
10.1016/j.cct.2018.09.014

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