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.
RCT Entities:
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 Dinsufficiency (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.
Authors: Robert E LaClair; Richard N Hellman; Sharon L Karp; Michael Kraus; Susan Ofner; Qian Li; Karen L Graves; Sharon M Moe Journal: Am J Kidney Dis Date: 2005-06 Impact factor: 8.860
Authors: A Nykjaer; D Dragun; D Walther; H Vorum; C Jacobsen; J Herz; F Melsen; E I Christensen; T E Willnow Journal: Cell Date: 1999-02-19 Impact factor: 41.582
Authors: Iris Sanchez; Roberto Mangoo-Karim; Jason R Stubbs; George P Yanev; James B Wetmore Journal: Int Urol Nephrol Date: 2012-05-30 Impact factor: 2.370
Authors: H A Bischoff-Ferrari; A Shao; B Dawson-Hughes; J Hathcock; E Giovannucci; W C Willett Journal: Osteoporos Int Date: 2009-12-03 Impact factor: 4.507
Authors: Sharon M Moe; Akber Saifullah; Robert E LaClair; Sohail A Usman; Zhangsheng Yu Journal: Clin J Am Soc Nephrol Date: 2010-01-07 Impact factor: 8.237
Authors: Luigi Francesco Morrone; Pergiorgio Bolasco; Corrado Camerini; Giuseppe Cianciolo; Adamasco Cupisti; Andrea Galassi; Sandro Mazzaferro; Domenico Russo; Luigi Russo; Mario Cozzolino Journal: J Nephrol Date: 2016-04-09 Impact factor: 3.902
Authors: William G Petchey; Ingrid J Hickman; Emma Duncan; Johannes B Prins; Carmel M Hawley; David W Johnson; Katherine Barraclough; Nicole M Isbel Journal: BMC Nephrol Date: 2009-12-10 Impact factor: 2.388