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

Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
Jan 2008
Citations:151
Influential Citations:5
Interventional (Human) Studies
80
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Methods
Double-blind, randomized, placebo-controlled pilot study in adults with CKD stages 3-4 (eGFR 15-59 mL/min/1.73 m2) and vitamin D insufficiency (25(OH)D ≤ 30 ng/mL) with serum PTH > 70 pg/mL.
Intervention
Cholecalciferol (Vitamin D3) 50,000 IU once weekly for 12 weeks; oral administration.
Results
25(OH)D rose significantly with cholecalciferol vs placebo; week 6 and week 12: P values P=0.001 and P=0.002. Mean baseline 25(OH)D was 17.3 ng/mL in the treatment group and increased to 49.4 ng/mL at 12 weeks in the treatment group. Nine of ten treated participants reached ≥30 ng/mL by 6 weeks. 1,25(OH)2D rose to 40.2 pg/mL at 12 weeks in the treatment group. PTH decreased by 31% with cholecalciferol vs 7% with placebo at 12 weeks, but this difference was not statistically significant (P = 0.07) due to high variability. No hypercalcemia or adverse events observed. Conclusion: Weekly cholecalciferol effectively corrects vitamin D insufficiency in CKD 3–4 and is safe; data suggest a possible PTH reduction but require larger, longer-term studies to confirm; early correction of vitamin D status in CKD is advisable.
Limitations
Small sample size (20 completing participants); as-treated analysis with postrandomization exclusions and withdrawals; short duration (12 weeks); high PTH variability limiting significance; no bone or cardiovascular outcomes; no head-to-head comparison with ergocalciferol; single-center study.

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, ...