Cholecalciferol (Vitamin D3) Therapy and Vitamin D Insufficiency in Patients with Chronic Kidney Disease: A Randomized Controlled Pilot Study |
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Affiliation: | 1. Graduate Program in Nutrition and Health Sciences, Atlanta, Georgia;2. Departments Biostatistics, Atlanta, Georgia;3. Medicine, Emory University, Atlanta, Georgia.;1. Tulane University Health Sciences Center, New Orleans, LA;2. Southeast Louisiana Veterans Health Care Systems, New Orleans, LA;3. Joslin Diabetes Center, Boston, MA;4. Diabetes-Endocrinology Center of Western NY, Buffalo, NY;5. Scott & White Clinic, Temple, TX;6. Harvard Medical School, Boston, MA;7. Emory University, Atlanta, GA;8. University of Nebraska, Omaha, NB;1. Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom;2. Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom;3. Channing Division of Network Medicine, Department of Medicine, Brigham and Women''s Hospital/Harvard Medical School, Boston, MA;4. Division of Preventive Medicine, Brigham and Women''s Hospital, Harvard Medical School, Boston, MA;1. Division of Nephrology and Kidney Research Institute, Department of Medicine, University of Washington, Seattle, Washington, USA;2. Department of Epidemiology, University of Washington, Seattle, Washington, USA;3. Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA;4. Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, VA Puget Sound Health Care System and the University of Washington, Seattle, Washington, USA |
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Abstract: | ObjectiveTo 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).MethodsIn 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.ResultsGeometric 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).ConclusionWeekly cholecalciferol supplementation appears to be an effective treatment to correct vitamin D status in patients with CKD. (Endocr Pract. 2008;14:10-17) |
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