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

Abstract

BackgroundKDOQI 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.MethodsThis 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).ResultsThe 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.ConclusionsThe 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.

Early introduction of oral paricalcitol in renal transplant recipients. An open-label randomized study

“…The proteinuria lowering effect of ergocalciferol in CKD patients with vitamin D deficiency was recently demonstrated . Based on our subgroup analyses, one might speculate that in a more Vitamin D‐sufficient population, there be little room for additional anti‐proteinuric effects exerted by VRDA.…”

The Role of Vitamin D in CKD Stages 3 to 4: Report of a Scientific Workshop Sponsored by the National Kidney Foundation

“…87,88 The effects of nutritional vitamin D, such as ergocalciferol, cholecalciferol, or calcifediol, on proteinuria are less clear, with both positive and null results. 89,90 Such intermediate end point trials may help identify populations of responders, most effective agents, and optimal doses for treatment before moving to clinical outcome studies.…”

Vitamin D Supplementation for Patients with Chronic Kidney Disease: A Systematic Review and Meta-analyses of Trials Investigating the Response to Supplementation and an Overview of Guidelines

“…The limited number of randomized controlled trials reporting the effects of treatment with vitamin D or its analogues on CKD-MBD related outcomes provided conflicting results [18][19][20][21][22][23][24][25][26][27][28][29][30][31]. Several studies also reported the effect of supplementation on renal function and proteinuria [32] and markers of endothelial and cardiovascular function and inflammation [33,34].…”