A double-blind, randomized, placebo-controlled trial of combined calcitriol and ergocalciferol versus ergocalciferol alone in chronic kidney disease with proteinuria

BMC Nephrol. 2017 Jan 14;18(1):19. doi: 10.1186/s12882-017-0436-6.

Abstract

Background: 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.

Methods: 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).

Results: 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.

Conclusions: 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.

Trial registration: (Thai Clinical Trials Registry (TCTR) 20140929002 ). Date of registration: September 27, 2014.

Keywords: CKD; Calcitriol; Ergocalciferol; Proteinuria; Vitamin D deficiency.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Blood Pressure
  • Calcitriol / therapeutic use*
  • Creatinine / urine
  • Double-Blind Method
  • Drug Therapy, Combination
  • Ergocalciferols / therapeutic use*
  • Female
  • Glomerular Filtration Rate
  • Humans
  • Male
  • Middle Aged
  • Proteinuria / complications
  • Proteinuria / drug therapy*
  • Proteinuria / metabolism
  • Renal Insufficiency, Chronic / complications
  • Renal Insufficiency, Chronic / drug therapy*
  • Renal Insufficiency, Chronic / metabolism
  • Severity of Illness Index
  • Thailand
  • Treatment Outcome
  • Vitamin D / analogs & derivatives
  • Vitamin D / blood
  • Vitamin D Deficiency / complications
  • Vitamin D Deficiency / drug therapy*
  • Vitamin D Deficiency / metabolism
  • Vitamins / therapeutic use*

Substances

  • Ergocalciferols
  • Vitamins
  • Vitamin D
  • 25-hydroxyvitamin D
  • Creatinine
  • Calcitriol