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

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

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.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Albuminuria
  • Cholecalciferol / therapeutic use*
  • Diabetes Mellitus, Type 2 / complications
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetic Nephropathies / drug therapy
  • Diabetic Nephropathies / etiology
  • Diabetic Nephropathies / prevention & control*
  • Diabetic Nephropathies / urine
  • Disease Progression
  • Docosahexaenoic Acids / therapeutic use*
  • Double-Blind Method
  • Eicosapentaenoic Acid / therapeutic use*
  • Fatty Acids, Omega-3 / therapeutic use
  • Female
  • Glomerular Filtration Rate
  • Humans
  • Male
  • Middle Aged
  • Vitamins / therapeutic use*

Substances

  • Fatty Acids, Omega-3
  • Vitamins
  • Cholecalciferol
  • Docosahexaenoic Acids
  • Eicosapentaenoic Acid