Effects of Long-Term Cholecalciferol Supplementation on Mineral Metabolism and Calciotropic Hormones in Chronic Kidney Disease

Abstract

Background: Data on the efficacy and safety of long-term vitamin D supplementation in chronic kidney disease (CKD) are scarce. We assessed the effects of the 12-month vitamin D₃ treatment on mineral metabolism and calciotropic hormones in patients with CKD stages 2–4. Methods: Eighty-seven patients (mean age 66 years, men/women 33/54) were randomized to cholecalciferol treatment with either 5,000 or 20,000 IU/week. Serum calcium, phosphate, 25(OH)D₃, 1,25(OH)₂D₃, PTH and urinary mineral concentrations were obtained at baseline and after 4, 8 and 12 months. Results: The median serum mineral concentrations were normal and not changed throughout the study. The number of hypercalciuric patients slightly increased with higher dose, but no sustained rise in calciuria was present. Vitamin D insufficiency/deficiency was revealed in 72 (83%) patients at baseline and 37 (43%) at month 12. The 25(OH)D₃ levels increased more with higher dose; a rise in 1,25(OH)₂D₃ was less impressive. The parathyroid hormone (PTH) concentrations were reduced, but the number of subjects with PTH below the lower limit for CKD stage 3 increased equally with both doses. Conclusions: Vitamin D insufficiency/deficiency in CKD significantly improved after the 12-month cholecalciferol treatment, with higher dose being more effective and equally safe. Further studies of vitamin D₃ effects on bone metabolism are warranted.

Modified-Release Calcifediol Effectively Controls Secondary Hyperparathyroidism Associated with Vitamin D Insufficiency in Chronic Kidney Disease

“…Many studies have evaluated vitamin D (either cholecalciferol or ergocalciferol) as a treatment for vitamin D insufficiency or SHPT in adults with predialysis CKD [25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42]. Most were open-label studies and some were conducted in patients exhibiting SHPT.…”

Vitamin D supplementation in pre-dialysis chronic kidney disease

“…Okša et al 36 reported similar decreases in PTH using either 5,000 IU or 20,000 IU cholecalciferol per week (~714 or 2857 IU/day). Hari et al 37 reported greater median reductions in PTH in Stage 2 (38.5%) compared with Stages 3 (25.2%) and 4 (15.2%).…”

“…Of the 17 studies, two studies were double-blind, randomized placebo-controlled trials; 29 , 30 6 were randomized controlled trials comparing cholecalciferol/ergocalciferol to active vitamin D analogs, 31 , 32 no treatment, 33 - 35 or different dose of cholecalciferol; 36 4 were prospective, observation trials of cholecalciferol 37 or ergocalciferol 38 - 40 and 4 were retrospective, observational studies of ergocalciferol 41 - 44 . One study 45 appears to be a secondary analysis of a parent study, 36 thus duplicate analyses are only reported for the parent study.…”

“…All studies reported significant improvements in 25(OH)D concentrations, although several studies did not reach a mean 25(OH)D concentration into the optimal range (≥ 30 ng/ml) after treatment, including a 12-wk study of cholecalciferol at 1,000 IU/day, 34 a single-dose cholecalciferol study of 300,000 IU followed up to 4 weeks (~10,714 IU/day), 33 two 5,000 IU/wk (~714 IU/day) cholecalciferol studies for 1 y 36 , 45 and three studies based on the 2003 KDOQI guidelines 2 for 16–24 wks (~1786–7143 IU/day ergocalciferol) 31 , 42 , 44 . Baseline serum 25(OH)D ranged from 13.4 to 22.0 ng/ml in those that achieved mean optimal concentrations 29 , 32 , 35 - 41 vs 8.5 to 17.2 ng/ml in those that did not achieve mean optimal serum 25(OH)D concentrations 31 , 33 , 34 , 36 , 42 , 44 , 45 .…”

“…Baseline serum 25(OH)D ranged from 13.4 to 22.0 ng/ml in those that achieved mean optimal concentrations 29 , 32 , 35 - 41 vs 8.5 to 17.2 ng/ml in those that did not achieve mean optimal serum 25(OH)D concentrations 31 , 33 , 34 , 36 , 42 , 44 , 45 . Lishmanov et al 41 retrospectively considered their treatment group as patients with an increase in serum 25(OH)D of at least 25%, thus group allocation was decided regardless of actual vitamin D supplementation.…”