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一项关于维生素D(每日低剂量和每周高剂量)对维生素D缺乏患者疗效的开放标签、随机、为期10周的前瞻性研究。

An open-label, randomized, 10 weeks prospective study on the efficacy of vitamin D (daily low dose and weekly high dose) in vitamin D deficient patients.

作者信息

Singh Vikram, Misra Arup K, Singh Mridu, Midha Naresh K, Kumar Bharat, Ambwani Sneha, Bohra Gopal K, Sharma Pramod K

机构信息

Department of Medicine, Dr. Ram Manohar Lohia Institute of Medical Sciences, Gomti Nagar, Lucknow, Uttar Pradesh, India.

Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Basni, Phase-1, Jodhpur, Rajasthan, India.

出版信息

J Family Med Prim Care. 2019 Jun;8(6):1958-1963. doi: 10.4103/jfmpc.jfmpc_272_19.

Abstract

BACKGROUND

Vitamin D is an important vitamin required to maintain normal skeletal as well as nonskeletal functions. The daily supplementation of vitamin D not only have poor adherence to the regimen but also of doubtful efficacy in deficient patients.

OBJECTIVES

The aim of this study was to compare the effect of oral high-dose vitamin D regimens (60,000 IU weekly) and daily low-dose vitamin D regimen of 1000 IU in mitigating symptoms and increase in serum levels of vitamin D in patients with hypovitaminosis D.

MATERIALS AND METHODS

A total of 90 patients aged 18-60 years with vitamin D deficiency (serum levels < 30 ng/mL) were enrolled. A total of 38 subjects received 60,000 IU of vitamin D weekly with 500 mg/day calcium and 40 subjects received a dose of 1000 IU of vitamin D daily with 500 mg/day calcium for 10 weeks. Baseline and follow-up total serum vitamin D levels and improvement in symptoms were measured within and between groups.

RESULTS

For high-dose vitamin D (60,000 IU weekly), the increase in mean serum vitamin D levels from baseline was 28.33 ng/mL over 10 weeks' treatment period; whereas for the low-dose group (1000 IU daily) the mean increment in serum vitamin D was 6.79 ng/mL for the same period. The mean difference in increase in serum vitamin D between two groups was highly significant ( < 0.001). In both the groups, decrease in myalgia as evaluated on visual analog scale was observed after 10 weeks.

CONCLUSIONS

High-dose vitamin D (60,000 IU weekly) regimen rapidly normalized 25(OH) D levels and ensure symptomatic relief earlier than daily dosing of 1000 IU vitamin D for same duration.

摘要

背景

维生素D是维持正常骨骼及非骨骼功能所需的一种重要维生素。每日补充维生素D不仅患者对该方案的依从性差,而且对维生素D缺乏患者的疗效也存疑。

目的

本研究旨在比较口服高剂量维生素D方案(每周60,000 IU)和每日低剂量1000 IU维生素D方案在缓解维生素D缺乏症患者症状及提高血清维生素D水平方面的效果。

材料与方法

共纳入90名年龄在18至60岁的维生素D缺乏患者(血清水平<30 ng/mL)。共有38名受试者每周接受60,000 IU维生素D加每日500 mg钙,40名受试者每日接受1000 IU维生素D加每日500 mg钙,为期10周。测量组内和组间的基线及随访时血清总维生素D水平以及症状改善情况。

结果

对于高剂量维生素D(每周60,000 IU),在10周的治疗期内,血清维生素D水平较基线的平均升高为28.33 ng/mL;而对于低剂量组(每日1000 IU),同期血清维生素D的平均升高为6.79 ng/mL。两组血清维生素D升高的平均差异非常显著(<0.001)。在两组中,10周后根据视觉模拟量表评估,肌痛均有所减轻。

结论

高剂量维生素D(每周60,000 IU)方案能使25(OH)D水平迅速恢复正常,并比每日服用1000 IU维生素D相同疗程能更早确保症状缓解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/abf3/6618212/f82e44a6ee5e/JFMPC-8-1958-g001.jpg

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