Cholecalciferol (vitamin D3) therapy and vitamin D insufficiency in patients with chronic kidney disease: a randomized controlled pilot study

Endocr Pract. Jan-Feb 2008;14(1):10-7. doi: 10.4158/EP.14.1.10.

Abstract

Objective: To investigate the efficacy of cholecalciferol (vitamin D3) in raising serum 25-hydroxyvitamin D (25[OH)]D) levels and reducing parathyroid hormone (PTH) levels in patients with chronic kidney disease (CKD).

Methods: In this double-blind, randomized controlled pilot study, participants with CKD stage 3 and 4 (estimated glomerular filtration rate, 15-59 mL/min/1.73 m2), vitamin D insufficiency (serum 25[OH]D <30 ng/mL), and serum intact PTH levels >70 pg/mL were randomly assigned to receive either 50 000 IU of cholecalciferol or placebo once weekly for 12 weeks. Primary outcomes (25[OH]D and PTH levels) were measured at baseline, week 6, and week 12. Secondary outcomes (1,25-dihydroxvitamin D and bone turnover markers) were measured at baseline and week 12. Because of skewed data distribution, statistical analyses were performed on a logarithmic scale. The difference between the group means was exponentiated to provide the geometric mean ratio. A linear mixed model using an unstructured variance-covariance matrix was used to examine change in the primary and secondary outcomes over time.

Results: Geometric mean serum 25(OH)D concentrations of the study groups were similar at baseline (P = .77). At week 6, a significant difference between the treatment and placebo groups was detected (P = .001); this difference was maintained at week 12 (P = .002). Among cholecalciferol-treated participants, serum 25(OH)D concentration increased on average from 17.3 ng/mL (95% confidence interval [CI], 11.8-25.2) at baseline to 49.4 ng/mL (95% CI, 33.9-72.0) at week 12. As-treated analysis indicated a trend toward lower PTH levels among cholecalciferol-treated participants (P = .07).

Conclusion: Weekly cholecalciferol supplementation appears to be an effective treatment to correct vitamin D status in patients with CKD.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acid Phosphatase / blood
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Alkaline Phosphatase / blood
  • Calcium / blood
  • Cholecalciferol / therapeutic use*
  • Collagen Type I / blood
  • Double-Blind Method
  • Humans
  • Isoenzymes / blood
  • Middle Aged
  • Parathyroid Hormone / blood
  • Peptides / blood
  • Pilot Projects
  • Placebos
  • Renal Insufficiency, Chronic / blood
  • Renal Insufficiency, Chronic / complications
  • Renal Insufficiency, Chronic / drug therapy*
  • Tartrate-Resistant Acid Phosphatase
  • Vitamin D / blood
  • Vitamin D Deficiency / blood
  • Vitamin D Deficiency / drug therapy*
  • Vitamin D Deficiency / etiology

Substances

  • Collagen Type I
  • Isoenzymes
  • Parathyroid Hormone
  • Peptides
  • Placebos
  • collagen type I trimeric cross-linked peptide
  • Vitamin D
  • Cholecalciferol
  • Alkaline Phosphatase
  • Acid Phosphatase
  • Tartrate-Resistant Acid Phosphatase
  • Calcium