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维生素 D 补充剂对终末期膝骨关节炎患者的疗效:一项双盲、随机对照试验的研究方案。

The effectiveness of vitamin D supplementation in patients with end-stage knee osteoarthritis: Study protocol for a double-blinded, randomized controlled trial.

机构信息

Department of Orthopaedics and Traumatology, Faculty of Medicine, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong SAR, China.

Department of Orthopaedics and Traumatology, Prince of Wales Hospital, Hong Kong SAR, China.

出版信息

PLoS One. 2024 Oct 21;19(10):e0309610. doi: 10.1371/journal.pone.0309610. eCollection 2024.


DOI:10.1371/journal.pone.0309610
PMID:39432457
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11493297/
Abstract

Osteoarthritis (OA) knee is one of the most common chronic degenerative conditions that imposes clinical and economic burdens on individuals and societies worldwide. Previous studies showed vitamin D levels correlated positively with lean muscle mass and grip strength, implying that vitamin D supplementation may improve muscle health in knee OA subjects. This randomized controlled trial (RCT) aims to compare the effects of vitamin D supplementation on knee muscle strength, physical function, pain, and sarcopenia status in patients with end-stage knee OA. Patients and outcome assessors will be blinded to group allocation. Fifty-six end-stage knee OA patients with vitamin D insufficiency fulfilling our inclusion criteria will be invited to participate in this study. Patients will be randomly assigned to take vitamin D supplementation (4,000 IU capsule daily) or placebo for six months. Measurements will be taken at baseline, three and six-month after the commencement of the vitamin D supplement, and 6-month after the interventional period. The primary outcome includes the isometric quadriceps and hamstring muscle strength measured by a hand-held dynamometer. Secondary outcomes include pain, performance-based and self-reported physical function and sarcopenia status. The success of this study will provide scientific evidence of whether the relatively cheap and well-tolerated vitamin D supplement can improve quadriceps muscle strength, physical function, pain symptoms, and sarcopenia status of this increasingly large population for end-stage knee OA patients. The study has great clinical significance given Hong Kong's lengthy and growing waiting list for complete knee replacement procedures. Trial registration: The trial was registered on clinicaltrials.gov (NCT05981534) on 31st July 2023.

摘要

骨关节炎(OA)膝是全球范围内最常见的慢性退行性疾病之一,给个人和社会带来了临床和经济负担。先前的研究表明,维生素 D 水平与瘦肌肉量和握力呈正相关,这意味着维生素 D 补充可能会改善膝骨关节炎患者的肌肉健康。这项随机对照试验(RCT)旨在比较维生素 D 补充对终末期膝骨关节炎患者的膝关节肌肉力量、身体功能、疼痛和肌肉减少症状态的影响。患者和结果评估者将对分组分配保持盲态。将邀请 56 名符合纳入标准的维生素 D 不足的终末期膝骨关节炎患者参加这项研究。患者将被随机分配服用维生素 D 补充剂(每天 4000IU 胶囊)或安慰剂,为期 6 个月。测量将在基线、开始补充维生素 D 后的第 3 个月和第 6 个月以及干预期后的 6 个月进行。主要结果包括通过手持测力计测量的等长股四头肌和腘绳肌力量。次要结果包括疼痛、基于表现的和自我报告的身体功能以及肌肉减少症状态。这项研究的成功将为相对廉价且耐受性良好的维生素 D 补充剂是否可以改善这个日益庞大的终末期膝骨关节炎患者群体的股四头肌力量、身体功能、疼痛症状和肌肉减少症状态提供科学证据。鉴于香港接受全膝关节置换手术的漫长且不断增长的候补名单,该研究具有重要的临床意义。试验注册:该试验于 2023 年 7 月 31 日在 clinicaltrials.gov(NCT05981534)上注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5cb/11493297/001f9e4b5dc0/pone.0309610.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5cb/11493297/917320b1847a/pone.0309610.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5cb/11493297/5e4d347b06e2/pone.0309610.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5cb/11493297/5deb5438fb6b/pone.0309610.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5cb/11493297/001f9e4b5dc0/pone.0309610.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5cb/11493297/917320b1847a/pone.0309610.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5cb/11493297/5e4d347b06e2/pone.0309610.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5cb/11493297/5deb5438fb6b/pone.0309610.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5cb/11493297/001f9e4b5dc0/pone.0309610.g004.jpg

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本文引用的文献

[1]
Functional biomaterials for osteoarthritis treatment: From research to application.

Smart Med. 2022-12-27

[2]
Long-term supplementation with 3200 to 4000 IU of vitamin D daily and adverse events: a systematic review and meta-analysis of randomized controlled trials.

Eur J Nutr. 2023-6

[3]
Long wait times for knee and hip total joint replacement in Canada: An isolated health system problem, or a symptom of a larger problem?

Osteoarthr Cartil Open. 2021-2-16

[4]
Vitamin D supplementation and exercise for improving physical function, body composition and metabolic health in overweight or obese older adults with vitamin D deficiency: a pilot randomized, double-blind, placebo-controlled trial.

Eur J Nutr. 2023-3

[5]
Increased recurrent falls experience in older adults with coexisting of sarcopenia and knee osteoarthritis: a cross-sectional study.

BMC Geriatr. 2021-12-15

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Does vitamin D improve symptomatic and structural outcomes in knee osteoarthritis? A systematic review and meta-analysis.

Aging Clin Exp Res. 2021-9

[7]
Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review.

JAMA. 2021-2-9

[8]
Is There Proof of Extraskeletal Benefits From Vitamin D Supplementation From Recent Mega Trials of Vitamin D?

JBMR Plus. 2021-1-4

[9]
End-stage knee osteoarthritis with and without sarcopenia and the effect of knee arthroplasty - a prospective cohort study.

BMC Geriatr. 2021-1-4

[10]
Non-surgical management of knee osteoarthritis: comparison of ESCEO and OARSI 2019 guidelines.

Nat Rev Rheumatol. 2021-1

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