title: A double-blind, randomized, placebo-controlled trial of combined calcitriol and ergocalciferol versus ergocalciferol alone in chronic kidney disease with proteinuria.
abstract: KDOQI guideline suggests that nutritional vitamin D should be supplemented in chronic kidney disease (CKD) patients who have vitamin D insufficiency/deficiency. However, there are scarce data regarding the additional benefit of active vitamin D supplement in CKD patients who were receiving nutritional vitamin D supplement. This study was conducted to explore the effect of adding active vitamin D to nutritional vitamin D supplement on proteinuria and kidney function in CKD with vitamin D insufficiency/deficiency.
  
  
  
  This double-blind, randomized placebo-controlled trial was performed to answer the above question. Sixty-eight patients with CKD stage 3-4, urine protein to creatinine ratio (UPCR) > 1 g/g, and serum 25OH-D level < 30 ng/mL were enrolled. Patients were randomly assigned to receive 12-week treatment with oral ergocalciferol plus placebo (n = 36) or oral ergocalciferol plus calcitriol (n = 32).
  
  
  
  The mean baseline values of UPCR of both groups were comparable (3.6 ± 3.8 g/g in combined group and 3.5 ± 3.0 g/g in ergocalciferol group). Following 12-week treatment, there were significant reductions in UPCR from baseline in both groups (2.3 ± 2.1 g/g in combined group and 2.4 ± 2.0 g/g in ergocalciferol group). The percentage reductions in UPCR of both groups were not significantly different. The mean eGFR and blood pressure did not differ between baseline and 12-week follow-up and between both groups. No severe hypercalcemia or serious side effects were noted in both groups.
  
  
  
  The proteinuria lowering effect of ergocalciferol in CKD patients with vitamin D deficiency was demonstrated. Additional calcitriol supplement did not have more effects on proteinuria.
  
  
  
  (Thai Clinical Trials Registry (TCTR) 20140929002 ). Date of registration: September 27, 2014.
authors.affiliation: Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, 1873, Rama 4 Rd., Pathumwan, Bangkok, 10330, Thailand. pesancerinus@hotmail.com.
authors.forename: Paweena
authors.initials: P
authors.lastname: Susantitaphong
authors.affiliation: Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, 1873, Rama 4 Rd., Pathumwan, Bangkok, 10330, Thailand.
authors.forename: Siriwan
authors.initials: S
authors.lastname: Nakwan
authors.affiliation: Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, 1873, Rama 4 Rd., Pathumwan, Bangkok, 10330, Thailand.
authors.forename: Sadudee
authors.initials: S
authors.lastname: Peerapornratana
authors.affiliation: Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, 1873, Rama 4 Rd., Pathumwan, Bangkok, 10330, Thailand.
authors.forename: Khajohn
authors.initials: K
authors.lastname: Tiranathanagul
authors.affiliation: Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, 1873, Rama 4 Rd., Pathumwan, Bangkok, 10330, Thailand.
authors.forename: Pisut
authors.initials: P
authors.lastname: Katavetin
authors.affiliation: Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, 1873, Rama 4 Rd., Pathumwan, Bangkok, 10330, Thailand.
authors.forename: Nattachai
authors.initials: N
authors.lastname: Srisawat
authors.affiliation: Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, 1873, Rama 4 Rd., Pathumwan, Bangkok, 10330, Thailand.
authors.forename: Kearkiat
authors.initials: K
authors.lastname: Praditpornsilpa
authors.affiliation: Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, 1873, Rama 4 Rd., Pathumwan, Bangkok, 10330, Thailand.
authors.forename: Somchai
authors.initials: S
authors.lastname: Eiam-Ong
mesh_terms: D000368:Aged; D001794:Blood Pressure; D002117:Calcitriol / Q000627:therapeutic use*; D003404:Creatinine / Q000652:urine; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004872:Ergocalciferols / Q000627:therapeutic use*; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D008297:Male; D008875:Middle Aged; D011507:Proteinuria / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D012720:Severity of Illness Index; D013785:Thailand; D016896:Treatment Outcome; D014807:Vitamin D / Q000031:analogs & derivatives / Q000097:blood; D014808:Vitamin D Deficiency / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D014815:Vitamins / Q000627:therapeutic use*
chemical_list: D004872:Ergocalciferols; D014815:Vitamins; D014807:Vitamin D; C104450:25-hydroxyvitamin D; D003404:Creatinine; D002117:Calcitriol
keywords: CKD; Calcitriol; Ergocalciferol; Proteinuria; Vitamin D deficiency