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三种维生素 D 剂量方案在三个月内提高和维持血清 25-羟维生素 D 水平的效果:一项随机、前瞻性研究。

Effectiveness of three Vitamin D dosing protocols on raising and maintaining blood serum levels of 25-hydroxyvitamin D over a three-month period: a randomized, prospective study.

机构信息

Department of Orthopedic Surgery, The Cleveland Clinic, Cleveland, OH, USA.

Cleveland Clinic-South Pointe Hospital, 20000 Harvard Ave, Warrensville Heights, OH, 44122, USA.

出版信息

Eur J Orthop Surg Traumatol. 2023 May;33(4):1201-1207. doi: 10.1007/s00590-022-03272-5. Epub 2022 May 10.

Abstract

INTRODUCTION

Vitamin D has gained attention in the medical community due to its critical role in calcium homeostasis and overall bone health. No standard vitamin D dosing protocol in fracture care has been established for patients deficient in 25-hydroxyvitamin D. This prospective and randomized study aimed to find a dosing regimen that would safely achieve and maintain a therapeutic level of 25-hydroxyvitamin D in deficient patients over three months.

MATERIALS AND METHODS

Between June 2016 and May 2017, 48 patients with baseline total 25-hydroxyvitamin D less than 30.0 ng/mL were randomly assigned to either group one (one dose of 100,000 international units (IU) of Vitamin D2) or group 2 (100,000 IU of Vitamin D2 once weekly for twelve weeks) or group 3 (50,000 IU of Vitamin D2 daily for ten days followed by 2,000 IU of Vitamin D3 daily for 74 days). Baseline serum levels were drawn followed by interval levels at week 2, 6 and 12. The primary outcome was to determine which protocol could achieve and maintain therapeutic levels of total 25-hydroxyvitamin D over the course of three months. Our secondary outcome was to monitor for negative side effects.

RESULTS

Group 1 did not show any statistically significant increase in serum levels and had no reported side effects. There was a statistically significant increase in serum total 25-hydroxyvitamin D in group 2 between all-time points except between weeks 6 and 12. Two (12.5%) participants in group 2 reported side effects. Group 3 had the greatest change in serum levels from weeks 0 to 2 but had a significant decrease between weeks 2 and 6. No change was seen between weeks 6 and 12. Three (17.5%) participants in group 3 reported side effects.

CONCLUSIONS

Group 2 sustained and maintained a satisfactory level of total 25-hydroxyvitamin D over three months without any severe side effects.

摘要

简介

由于维生素 D 在钙稳态和整体骨骼健康中起着关键作用,它在医学界受到了关注。对于 25-羟维生素 D 缺乏的骨折患者,尚未建立标准的维生素 D 剂量方案。本前瞻性、随机研究旨在寻找一种安全的剂量方案,以在三个月内使缺乏症患者的 25-羟维生素 D 达到并维持治疗水平。

材料和方法

2016 年 6 月至 2017 年 5 月,将 48 名基线总 25-羟维生素 D 低于 30.0ng/ml 的患者随机分为三组:一组(一次 100,000 国际单位 (IU) 的维生素 D2)、二组(每周一次 100,000 IU 的维生素 D2,共 12 周)或三组(50,000 IU 的维生素 D2,每日一次,持续 10 天,然后每日 2,000 IU 的维生素 D3,持续 74 天)。在基线时抽取血清水平,然后在第 2、6 和 12 周时抽取间隔水平。主要结果是确定哪种方案可以在三个月内达到并维持治疗水平的总 25-羟维生素 D。我们的次要结果是监测副作用。

结果

第 1 组的血清水平没有明显增加,也没有报告任何副作用。第 2 组的血清总 25-羟维生素 D 在所有时间点都有统计学显著增加,除了第 6 周和第 12 周之间。第 2 组有 2 名(12.5%)参与者报告有副作用。第 3 组在第 0 周至第 2 周时血清水平变化最大,但在第 2 周至第 6 周时显著下降。第 6 周和第 12 周之间没有变化。第 3 组有 3 名(17.5%)参与者报告有副作用。

结论

第 2 组在三个月内持续维持了令人满意的总 25-羟维生素 D 水平,没有任何严重的副作用。

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