Choi Han Seok, Chung Yoon-Sok, Choi Yong Jun, Seo Da Hea, Lim Sung-Kil
Division of Endocrinology and Metabolism, Department of Internal Medicine, Dongguk University Ilsan Hospital, Koyang, Gyeonggi-do, South Korea.
Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, South Korea.
Osteoporos Sarcopenia. 2016 Dec;2(4):228-237. doi: 10.1016/j.afos.2016.09.004. Epub 2016 Oct 24.
There has been no prospective study that examined intramuscular injection of high-dose vitamin D in Korean adults. The aim of this study was to assess the efficacy and safety of high-dose vitamin D after intramuscular injection in Korean adults with vitamin D deficiency.
This study was a 24-week, prospective, multicenter, randomized, double-blind, placebo-controlled trial. A total of 84 subjects ≥19 and <65 years of age were randomly allocated to either the vitamin D or placebo group in a 2:1 ratio. After randomization, a single injection of plain vitamin D 200,000 IU or placebo was intramuscularly administered. If serum 25-hydroxyvitamin D (25[OH]D) concentrations were <30 ng/mL on week 12 or thereafter, a repeat injection was administered.
After a single intramuscular injection of vitamin D to adults with vitamin D deficiency, the proportion of subjects with serum 25(OH)D concentrations ≥30 ng/mL within 12 weeks was 46.4% in the vitamin D group and 3.6% in the placebo group (p < 0.0001). The proportion of subjects with serum 25(OH)D concentrations ≥30 ng/mL within 24 weeks was 73.2% in the vitamin D group and 3.6% in the placebo group (p < 0.0001). Mean change in serum 25(OH)D concentrations at weeks 12 and 24 after vitamin D injection was 12.8 ± 8.1 and 21.5 ± 8.1 ng/mL, respectively, in the vitamin D group, with no significant changes in the placebo group. Serum parathyroid hormone concentrations showed a significant decrease in the vitamin D group but no change in the placebo group.
Intramuscular injection of vitamin D 200,000 IU was superior to placebo in terms of its impact on serum 25(OH)D concentrations, and is considered to be safe and effective in Korean adults with vitamin D deficiency.
此前尚无针对韩国成年人肌肉注射大剂量维生素D的前瞻性研究。本研究旨在评估肌肉注射大剂量维生素D对维生素D缺乏的韩国成年人的疗效和安全性。
本研究为一项为期24周的前瞻性、多中心、随机、双盲、安慰剂对照试验。共有84名年龄在19岁及以上且小于65岁的受试者以2:1的比例随机分配至维生素D组或安慰剂组。随机分组后，肌肉注射一次普通维生素D 200,000 IU或安慰剂。如果在第12周及之后血清25-羟维生素D（25[OH]D）浓度<30 ng/mL，则再次注射。
对维生素D缺乏的成年人单次肌肉注射维生素D后，维生素D组在12周内血清25(OH)D浓度≥30 ng/mL的受试者比例为46.4%，安慰剂组为3.6%（p<0.0001）。维生素D组在24周内血清25(OH)D浓度≥30 ng/mL的受试者比例为73.2%，安慰剂组为3.6%（p<0.0001）。维生素D注射后第周和24周时，维生素D组血清25(OH)D浓度的平均变化分别为12.8±8.1和21.5±8.1 ng/mL，安慰剂组无显著变化。维生素D组血清甲状旁腺激素浓度显著降低，而安慰剂组无变化。
肌肉注射200,000 IU维生素D在影响血清25(OH)D浓度方面优于安慰剂，且被认为对维生素D缺乏的韩国成年人安全有效。
