Department of Internal Medicine, Phramongkutklao Hospital, Bangkok, Thailand.
Int J Clin Pharm. 2014 Aug;36(4):771-8. doi: 10.1007/s11096-014-9958-1. Epub 2014 May 23.
Vitamin D deficiency is a common problem worldwide. Several studies have shown an association between vitamin D deficiency and the increased risk of metabolic syndrome. No previous study has compared the efficacy and safety of ergocalciferol at 40,000 versus 20,000 IU/week in patients with metabolic syndrome.
To evaluate the efficacy of ergocalciferol supplementation on serum 25-hydroxyvitamin D [25(OH)D] concentrations and to examine safety parameters in metabolic syndrome patients.
Outpatient department of Phramongkutklao Hospital, Bangkok, Thailand.
A randomized, double-blinded, parallel study was conducted in metabolic syndrome patients with vitamin D deficiency [25(OH)D <20 ng/mL]. Ninety patients were randomly assigned into three groups of 30 patients each. Group 1 was given two capsules of placebo/week, group 2 was given ergocalciferol 20,000 IU/week, and group 3 was given ergocalciferol 40,000 IU/week for 8 weeks.
serum 25(OH)D concentrations, serum calcium, safety, and corrected QT (QTc) interval.
Of the 90 patients enrolled, 84 patients completed the study. At the end of the study, the mean serum 25(OH)D in groups 2 and 3 significantly increased from the baseline (15.1 and 14.3 to 26.8 and 30.0 ng/mL, respectively). The increase in serum 25(OH)D in groups 2 and 3 were comparable and significantly greater than that of the placebo group. The percentage number of patients achieving normal vitamin D levels in groups 1, 2 and 3 were 3.3, 33.3, and 60.0 %, respectively, which were significantly different between groups (p < 0.001). Adverse reactions in both ergocalciferol treatment groups were not different from the placebo group (p > 0.05). Serum calcium levels did not change within and between groups of treatment. No significant change in QTc was observed in any patient.
Both 20,000 and 40,000 IU/week of ergocalciferol supplementation for 8 weeks were able to increase serum 25(OH)D concentrations significantly. However, more patients in the ergocalciferol 40,000 IU/week treatment group achieved a normal serum 25(OH)D level than in the group which received 20,000 IU/week. Clinicians would have informed of choosing the dosing regimen of ergocalciferol in metabolic syndrome patients.
维生素 D 缺乏是一个全球性的常见问题。多项研究表明，维生素 D 缺乏与代谢综合征风险增加之间存在关联。以前没有研究比较过每周给予麦角钙化醇 40000IU 与 20000IU 对代谢综合征患者的疗效和安全性。
评估麦角钙化醇补充剂对血清 25-羟维生素 D [25(OH)D]浓度的疗效，并检查代谢综合征患者的安全性参数。
泰国曼谷玛希隆大学医院的门诊部。
对维生素 D 缺乏[25(OH)D <20ng/mL]的代谢综合征患者进行了一项随机、双盲、平行研究。90 例患者随机分为 3 组，每组 30 例。第 1 组每周给予 2 粒安慰剂，第 2 组给予麦角钙化醇 20000IU/周，第 3 组给予麦角钙化醇 40000IU/周，共 8 周。
血清 25(OH)D 浓度、血清钙、安全性和校正 QT（QTc）间期。
在纳入的 90 例患者中，84 例完成了研究。研究结束时，第 2 组和第 3 组的平均血清 25(OH)D 水平均较基线水平显著升高（分别为 15.1 和 14.3 至 26.8 和 30.0ng/mL）。第 2 组和第 3 组的血清 25(OH)D 升高幅度相似，明显大于安慰剂组。第 1、2 和 3 组中达到正常维生素 D 水平的患者比例分别为 3.3%、33.3%和 60.0%，组间差异有统计学意义（p<0.001）。麦角钙化醇治疗组的不良反应与安慰剂组无差异（p>0.05）。治疗组血清钙水平在组内和组间均无变化。在任何患者中均未观察到 QTc 有显著变化。
每周给予麦角钙化醇 20000IU 和 40000IU 均可显著增加血清 25(OH)D 浓度。然而，与每周接受 20000IU 麦角钙化醇治疗的患者相比，更多的患者在每周接受 40000IU 麦角钙化醇治疗后达到正常的血清 25(OH)D 水平。临床医生在选择代谢综合征患者的麦角钙化醇治疗方案时会考虑到这些信息。
