Cholecalciferol (vitamin D3) therapy and vitamin D insufficiency in patients with chronic kidney disease: a randomized controlled pilot study.
What this study found
Cholecalciferol effectively raised 25(OH)D and was safe, with a trend toward lowering PTH. In the active arm, 25(OH)D increased from 17.3 ng/mL at baseline to 49.4 ng/mL at week 12, with significant improvement by week 6 (P = .001) and week 12 (P = .002). PTH decreased by 31% in the cholecalciferol group versus 7% in placebo, but the reduction was only a trend in the as-treated analysis (P = .07). No hypercalcemia, no significant calcium change, and no adverse events were reported; bone turnover markers were unchanged.
- Study & population
- Randomized, double-blind, placebo-controlled pilot study in clinically stable adults with chronic kidney disease stages 3-4 and vitamin D insufficiency with elevated PTH.
- Intervention
- Cholecalciferol (vitamin D3) 50,000 IU was given orally once weekly for 12 weeks in a double-blind randomized trial, compared with placebo.
- Key limitation
- This was a small pilot study with only 10 analyzed participants in the active arm and a short 12-week duration.
View source
Open PDFOriginal 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.