Cholecalciferol v. ergocalciferol for 25-hydroxyvitamin D (25(OH)D) repletion in chronic kidney disease: a randomised clinical trial.
Cholecalciferol v. ergocalciferol for 25-hydroxyvitamin D (25(OH)D) repletion in chronic kidney disease: a randomised clinical trial.
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DOI：
10.1017/s000711451600427x
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发表时间：
2016-12
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影响因子：
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通讯作者：
Stubbs JR
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作者：
Wetmore JB;Kimber C;Mahnken JD;Stubbs JR
慢性肾脏疾病（CKD）患者表现出复杂的矿物质代谢紊乱和维生素D缺乏症的高发。然而，25-羟基维生素D （25(OH)D）补充的最佳方法尚不清楚，并且缺乏分析胆钙化醇和麦角钙化醇在该人群中比较功效的试验。我们在44名非透析依赖的3-5期CKD患者中进行了一项随机临床试验，每周使用1250 μg （50000 IU）的胆钙化醇与每周使用1250 μg （50000 IU）的麦角钙化醇，持续12周。主要结局是从基线到第12周（治疗后立即）总25(OH)D的变化。二次分析包括从基线到第18周（治疗后6周）的1,25-二羟基维生素D （1,25(OH)2D）、甲状旁腺激素（PTH）、25(OH)D和1,25(OH)2D的D2和D3亚部分以及总25(OH)D的变化。从基线到第12周，胆钙化醇治疗总25(OH)D （45.0 (SD 16.5) ng/ml）比麦角钙化醇（30.7 (SD 15.3) ng/ml）变化更大（P < 0.01）；这一观察结果部分是由于麦角钙化醇大量减少了25(OH)D3亚部分。然而，在停止治疗后，从基线到第18周，胆钙化醇组和麦角钙化醇组的总25(OH)D变化无统计学差异(分别为22.4 （SD 12.7）和17.6 (SD 8.9) ng/ml；P = 0·17)。我们观察到，在血清PTH或125 (OH)2D的变化方面，这些疗法之间没有显著差异。与麦角钙化醇相比，在非透析依赖性CKD患者进行积极治疗时，胆钙化醇治疗在提高血清25(OH)D方面更有效。然而，在治疗停止后，25(OH)D水平在两组中都显著下降，这表明需要维持治疗来维持水平。
Patients with chronic kidney disease (CKD) demonstrate complex mineral metabolism derangements and a high prevalence of vitamin D deficiency. However, the optimal method of 25-hydroxyvitamin D (25(OH)D) repletion is unknown, and trials analysing the comparative efficacy of cholecalciferol and ergocalciferol in this population are lacking. We conducted a randomised clinical trial of cholecalciferol 1250 μg (50 000 IU) weekly v. ergocalciferol 1250 μg (50 000 IU) weekly for 12 weeks in forty-four non-dialysis-dependent patients with stage 3–5 CKD. The primary outcome was change in total 25(OH)D from baseline to week 12 (immediately after therapy). Secondary analyses included the change in 1,25-dihydroxyvitamin D (1,25(OH)2D), parathyroid hormone (PTH), D2 and D3 sub-fractions of 25(OH)D and 1,25(OH)2D and total 25(OH)D from baseline to week 18 (6 weeks after therapy). Cholecalciferol therapy yielded a greater change in total 25(OH)D (45·0 (SD 16·5) ng/ml) v. ergocalciferol (30·7 (SD 15·3) ng/ml) from baseline to week 12 (P < 0·01); this observation partially resulted from a substantial reduction in the 25(OH)D3 sub-fraction with ergocalciferol. However, following cessation of therapy, no statistical difference was observed for total 25(OH)D change from baseline to week 18 between cholecalciferol and ergocalciferol groups (22·4 (SD 12·7) v. 17·6 (SD 8·9) ng/ml, respectively; P = 0·17). We observed no significant difference between these therapies with regard to changes in serum PTH or 1,25(OH)2D. Therapy with cholecalciferol, compared with ergocalciferol, is more effective at raising serum 25(OH)D in non- dialysis-dependent CKD patients while active therapy is ongoing. However, levels of 25(OH)D declined substantially in both arms following cessation of therapy, suggesting the need for maintenance therapy to sustain levels.