PDF(Pubmed)
Abstract：
UNASSIGNED: Nocturnal leg cramps (NLCs) are sudden contractions of the leg muscles, usually in the posterior calf muscles at night, affecting sleep quality. Because the precise pathophysiology of NCLs is unclear, different interventions have been proposed. There is conflicting evidence regarding the efficacy of conventional interventions in preventing cramps. Thus, the present study aims to investigate the effects of vitamin K2 for NLCs in a prospective randomized, double-blind, controlled trial.
UNASSIGNED: This multicenter, randomized, double-blind, placebo-controlled clinical study will enroll older age (≥65-year-old) with two or more documented episodes of NLCs during 2 weeks of screening. Participants will be randomized to receive vitamin K2 or a similar-looking placebo for 8 weeks in a 1:1 ratio. Follow-up visits will be scheduled each week at the beginning of 4-week intervention, then participants will be visited semimonthly. The primary outcome is the difference in the mean number of NLCs per week in the vitamin K2 and placebo arms. The secondary outcomes include the severity and duration of NLCs in the vitamin K2 and placebo arms. Two hundred patients will be needed, for this two-treatment parallel design study, to achieve a probability is 90% that the study will detect a treatment difference at a two-sided 0.04 significance level, if the difference between treatments is 3.6 (difference in means between treatment arms) NLC events.
UNASSIGNED: Nocturnal Leg Cramps (NLCs) are a common musculoskeletal disorder in the general population, but effective and safe interventions have not been established. Our previous study has shown vitamin K2 was effective to reduce the frequency, severity, and duration of dialysis-related muscle cramps with a good safety profile. This randomized controlled trial (RCT) of rigorous methodological design will help to establish the effectiveness of vitamin K2 for the management of NLCs in older population. The findings of this RCT will encourage the studies of vitamin K2 in musculoskeletal disorders.
UNASSIGNED: www.ClinicalTrials.gov, identifier, NCT05547750.
UNASSIGNED: This multicenter, randomized, double-blind, placebo-controlled clinical study will enroll older age (≥65-year-old) with two or more documented episodes of NLCs during 2 weeks of screening. Participants will be randomized to receive vitamin K2 or a similar-looking placebo for 8 weeks in a 1:1 ratio. Follow-up visits will be scheduled each week at the beginning of 4-week intervention, then participants will be visited semimonthly. The primary outcome is the difference in the mean number of NLCs per week in the vitamin K2 and placebo arms. The secondary outcomes include the severity and duration of NLCs in the vitamin K2 and placebo arms. Two hundred patients will be needed, for this two-treatment parallel design study, to achieve a probability is 90% that the study will detect a treatment difference at a two-sided 0.04 significance level, if the difference between treatments is 3.6 (difference in means between treatment arms) NLC events.
UNASSIGNED: Nocturnal Leg Cramps (NLCs) are a common musculoskeletal disorder in the general population, but effective and safe interventions have not been established. Our previous study has shown vitamin K2 was effective to reduce the frequency, severity, and duration of dialysis-related muscle cramps with a good safety profile. This randomized controlled trial (RCT) of rigorous methodological design will help to establish the effectiveness of vitamin K2 for the management of NLCs in older population. The findings of this RCT will encourage the studies of vitamin K2 in musculoskeletal disorders.
UNASSIGNED: www.ClinicalTrials.gov, identifier, NCT05547750.
摘要：
未经证实：夜间腿部痉挛（NLC）是腿部肌肉的突然收缩，通常在夜间小腿后部肌肉，影响睡眠质量。因为NCL的确切病理生理学尚不清楚，提出了不同的干预措施。关于常规干预措施在预防抽筋方面的功效，存在相互矛盾的证据。因此，本研究旨在研究维生素K2对NLC的影响，双盲,对照试验。
未经评估：此多中心，随机化，双盲,安慰剂对照临床研究将纳入年龄较大(≥65岁)的患者,在2周的筛查期间有2次或2次以上记录的NLCs发作.参与者将以1：1的比例随机接受维生素K2或类似的安慰剂8周。在为期4周的干预开始时，每周都会安排后续访问，然后将每半月访问参与者。主要结果是维生素K2和安慰剂组每周平均NLC数量的差异。次要结果包括维生素K2和安慰剂组中NLC的严重程度和持续时间。需要两百名病人,对于这项双处理并行设计研究，为了达到90%的概率，研究将在双侧0.04显著性水平上检测到治疗差异，如果治疗之间的差异为3.6（治疗组之间的均值差异）NLC事件。
未经证实：夜间腿部痉挛（NLCs）是普通人群中常见的肌肉骨骼疾病，但是尚未建立有效和安全的干预措施。我们之前的研究表明，维生素K2可有效降低频率，严重程度,和透析相关肌肉痉挛的持续时间，具有良好的安全性。这项严格的方法学设计的随机对照试验（RCT）将有助于确定维生素K2在老年人群中管理NLC的有效性。这项RCT的发现将鼓励维生素K2在肌肉骨骼疾病中的研究。
UNASSIGNED：www.ClinicalTrials.gov,标识符,NCT05547750。
未经评估：此多中心，随机化，双盲,安慰剂对照临床研究将纳入年龄较大(≥65岁)的患者,在2周的筛查期间有2次或2次以上记录的NLCs发作.参与者将以1：1的比例随机接受维生素K2或类似的安慰剂8周。在为期4周的干预开始时，每周都会安排后续访问，然后将每半月访问参与者。主要结果是维生素K2和安慰剂组每周平均NLC数量的差异。次要结果包括维生素K2和安慰剂组中NLC的严重程度和持续时间。需要两百名病人,对于这项双处理并行设计研究，为了达到90%的概率，研究将在双侧0.04显著性水平上检测到治疗差异，如果治疗之间的差异为3.6（治疗组之间的均值差异）NLC事件。
未经证实：夜间腿部痉挛（NLCs）是普通人群中常见的肌肉骨骼疾病，但是尚未建立有效和安全的干预措施。我们之前的研究表明，维生素K2可有效降低频率，严重程度,和透析相关肌肉痉挛的持续时间，具有良好的安全性。这项严格的方法学设计的随机对照试验（RCT）将有助于确定维生素K2在老年人群中管理NLC的有效性。这项RCT的发现将鼓励维生素K2在肌肉骨骼疾病中的研究。
UNASSIGNED：www.ClinicalTrials.gov,标识符,NCT05547750。
