Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and Phramongkutklao College of Medicine, 315 Ratchawithi Road, Ratchathewi district, 10400, Bangkok, Thailand.
Aging Clin Exp Res. 2020 Jan;32(1):41-48. doi: 10.1007/s40520-019-01151-4. Epub 2019 Feb 19.
Vitamin D inadequacy is common in institutionalized post-menopausal women who are at the highest risk for osteoporotic fracture.
To evaluate efficacy and safety of ergocalciferol 40,000 versus 100,000 IU per week for 12 weeks for vitamin D inadequacy in institutionalized postmenopausal women.
A randomized double-blinded placebo-controlled trial was conducted in 94 institutionalized subjects with baseline 25(OH)D levels < 30 ng/mL. Subjects were randomized to receive ergocalciferol 40,000 (standard dose) or ergocalciferol 100,000 IU (high dose) per week. Serum 25(OH)D levels, calcium, phosphate, handgrip strength, time up and go (TUG) test and quality of life by EQ-5D-5L were measured at baseline and 12 weeks after randomization.
Of the 94 subjects enrolled, 85 subjects completed the study. Subjects in the high dose group had higher mean 25(OH)D levels than subjects in the standard group (51.73 ± 19.35 and 34.5 ± 9.12, p < 0.001). More subjects in the high dose group (90.9%) achieved optimal 25(OH)D levels (> 30 ng/mL) than those in the standard group (65.9%), p = 0.007. In a subgroup analysis of subjects with vitamin D deficiency (< 20 ng/mL, n = 44) and severe vitamin D deficiency (< 10 ng/mL, n = 9), more subjects in the high dose group achieved optimal 25(OH)D levels than those in the standard group (88% and 100% versus 47.4% and 16.7% with p of 0.007 and 0.018, respectively). There were no differences in handgrip strength, TUG, EQ-5D-5L and adverse events between groups.
DISCUSSION/CONCLUSIONS: Subjects who received high dose ergocalciferol achieved more optimal 25(OH)D levels than those who received standard dose. High dose ergocalciferol is preferred to optimize 25(OH)D levels in subjects with severe vitamin D deficiency.
维生素 D 不足在绝经后住院女性中很常见，而她们正是骨质疏松性骨折风险最高的人群。
评估每周口服 40,000IU 或 100,000IU 麦角钙化醇治疗 12 周对绝经后住院女性维生素 D 不足的疗效和安全性。
在 94 名基线 25(OH)D 水平<30ng/mL 的绝经后住院女性中进行了一项随机、双盲、安慰剂对照试验。受试者被随机分配接受每周 40,000IU（标准剂量）或 100,000IU（高剂量）麦角钙化醇。在随机分组后 12 周时测量血清 25(OH)D 水平、钙、磷、握力、计时起立行走测试（TUG）和 EQ-5D-5L 生活质量。
94 名入组患者中，85 名完成了研究。高剂量组的平均 25(OH)D 水平高于标准剂量组（51.73±19.35 和 34.5±9.12，p<0.001）。高剂量组（90.9%）达到最佳 25(OH)D 水平（>30ng/mL）的患者比例高于标准剂量组（65.9%），p=0.007。在维生素 D 缺乏症（<20ng/mL，n=44）和严重维生素 D 缺乏症（<10ng/mL，n=9）亚组分析中，高剂量组达到最佳 25(OH)D 水平的患者比例高于标准剂量组（分别为 88%和 100%比 47.4%和 16.7%，p 值分别为 0.007 和 0.018）。两组之间的握力、TUG、EQ-5D-5L 和不良事件无差异。
讨论/结论：接受高剂量麦角钙化醇的患者比接受标准剂量的患者获得了更高的最佳 25(OH)D 水平。高剂量麦角钙化醇更有利于纠正严重维生素 D 缺乏患者的 25(OH)D 水平。
