title: An open label, randomized controlled study of oral calcitriol for the treatment of proteinuria in patients with diabetic kidney disease.
abstract: BACKGROUND
  The progression of diabetic kidney disease (DKD) is highly correlated with proteinuria. Previous studies have suggested that vitamin D treatment may reduce proteinuria and has the potential to delay the progression of renal disease.
  
  
  OBJECTIVE
  To evaluate efficacy of oral calcitriol to decrease proteinuria in type 2 diabetic mellitus (T2DM) patients with DKD.
  
  
  METHODS
  In this 16-week, open label, prospective, randomized controlled study, 91 patients with T2DM with estimated glomerular filtration rate (eGFR) greater than 15 ml/min/1.73 m2 and urine protein to creatinine ratio (UPCR) greater than 1 g/g were enrolled. They were randomly assigned to receive either oral calcitriol 0.5 mcg twice weekly (n = 46) or without oral calcitriol (n = 45). The primary outcome was determined by the change of UPCR from baseline after 16 weeks of treatment of both groups.
  
  
  RESULTS
  At randomization, the mean UPCR was 3.7 + 2.2 g/g in the calcitriol group and 3.4 +/- 2.1 g/g in the control group. The mean UPCR at 16-week follow-up was 2.9 +/- 1.7 g/g in the calcitriol group and 3.5 +/- 2.3 g/g in the control group. Percent changes in UPCR from baseline to the last evaluation in the calcitriol and control groups were -18.7% and +9.9% (p < 0.01) respectively. Patients with 30% or more decrement in proteinuria occurred 43.5% of the time in the calcitriol group and 11.1% in the control group (p < 0.01). The eGFR and blood pressure did not differ significantly between the two groups. No serious adverse side effects were noted in either group.
  
  
  CONCLUSIONS
  Calcitriol treatment can reduce proteinuria in patients with DKD without serious adverse events.
authors.affiliation: Department of Medicine, Rajavithi Hospital, College of Medicine, Raangsit University, Bangkok, Thailand. krairit@yahoo.com
authors.forename: Udom
authors.initials: U
authors.lastname: Krairittichai
authors.forename: Rungrawee
authors.initials: R
authors.lastname: Mahannopkul
authors.forename: Sakarn
authors.initials: S
authors.lastname: Bunnag
mesh_terms: D000284:Administration, Oral; D000368:Aged; D002117:Calcitriol / Q000008:administration & dosage*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003928:Diabetic Nephropathies / Q000150:complications*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011507:Proteinuria / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D014815:Vitamins / Q000008:administration & dosage*
chemical_list: D014815:Vitamins; D002117:Calcitriol