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Effect of Vitamin K2 on Postural Sway in Older People Who Fall: A Randomized Controlled Trial.

ABSTRACT: OBJECTIVES:Vitamin K is thought to be involved in both bone health and maintenance of neuromuscular function. We tested the effect of vitamin K2 supplementation on postural sway, falls, healthcare costs, and indices of physical function in older people at risk of falls. DESIGN:Parallel-group double-blind randomized placebo-controlled trial. SETTING:Fourteen primary care practices in Scotland, UK. PARTICIPANTS:A total of 95 community-dwelling participants aged 65 and older with at least two falls, or one injurious fall, in the previous year. INTERVENTION:Once/day placebo, 200 ?g or 400 ?g of oral vitamin K2 for 1 year. MEASUREMENTS:The primary outcome was anteroposterior sway measured using sway plates at 12?months, adjusted for baseline. Secondary outcomes included the Short Physical Performance Battery, Berg Balance Scale, Timed Up & Go Test, quality of life, health and social care costs, falls, and adverse events. RESULTS:Mean participant age was 75 (standard deviation [SD] = 7) years. Overall, 58 of 95 (61%) were female; 77 of 95 (81%) attended the 12-month visit. No significant effect of either vitamin K2 dose was seen on the primary outcome of anteroposterior sway (200 ?g vs placebo: -.19?cm [95% confidence interval [CI] -.68 to .30; P = .44]; 400 ?g vs placebo: .17?cm [95% CI -.33 to .66; P = .50]; or 400 ?g vs 200 ?g: .36?cm [95% CI -.11 to .83; P = .14]). Adjusted falls rates were similar in each group. No significant treatment effects were seen for other measures of sway or secondary outcomes. Costs were higher in both vitamin K2 arms than in the placebo arm. CONCLUSION:Oral vitamin K2 supplementation did not improve postural sway or physical function in older people at risk of falls. J Am Geriatr Soc 67:2102-2107, 2019.

SUBMITTER: Witham MD

PROVIDER: S-EPMC6851824 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Effect of Vitamin K2 on Postural Sway in Older People Who Fall: A Randomized Controlled Trial.

Witham Miles D MD Price Rosemary J G RJG Band Margaret M MM Hannah Michael S MS Fulton Roberta L RL Clarke Clare L CL Donnan Peter T PT McNamee Paul P Cvoro Vera V Soiza Roy L RL

Journal of the American Geriatrics Society 20190618 10

<h4>Objectives</h4>Vitamin K is thought to be involved in both bone health and maintenance of neuromuscular function. We tested the effect of vitamin K2 supplementation on postural sway, falls, healthcare costs, and indices of physical function in older people at risk of falls.<h4>Design</h4>Parallel-group double-blind randomized placebo-controlled trial.<h4>Setting</h4>Fourteen primary care practices in Scotland, UK.<h4>Participants</h4>A total of 95 community-dwelling participants aged 65 and ...[more]

PMID: 31211416

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Project description:IntroductionNocturnal 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.Methods and analysisThis 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.DiscussionNocturnal 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.Clinical trial registrationwww.ClinicalTrials.gov, identifier, NCT05547750.

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Project description:BACKGROUND:Diminished somatosensory function is a critical age-related change which is related to postural instability in the older population. Footwear is a cost-effective way to modulate the postural stability by altering sensorimotor inputs via mechanoreceptors on the plantar surface of the feet. Compared to insoles with indentions in the entire surface, we innovatively developed a textured insole with site-specific nodulous protrudous. This study thus aimed to investigate the immediate effect of the nodulous insole and supporting surface condition on static postural stability and lower limb muscle activation for healthy older women. METHODS:This is a single-session study with repeated measurements. Twenty-three healthy older women stood on the firm (i.e., concrete floor) and foam surfaces with their eyes open in the three footwear conditions, namely barefoot, plain shoes and shoes with an innovative textured insole, for 30 seconds. Static postural sway and muscle activation of biceps femoris (BF), vastus lateralis (VL), tibialis anterior (TA), and lateral gastrocnemius (LG) of the dominant leg were measured during each testing condition. RESULTS:Compared to a firm surface, standing on the foam could significantly increase the body sway and lower limb muscle activation (p<0.05). When standing on the foam, compared to barefoot, wearing footwear significantly decreased the VL and TA muscle activation and minimize the postural sway in medial-lateral and anterior-posterior direction, while the influence is larger for the shoes with nodulous insloe compared to the plain shoes. No significant differences between the footwear conditions for static stability and muscle activation were observed on firm surface condition. CONCLUSIONS:For older women, footwear could improve the postural stability in the unstable surface, particularly the footwear with nodulous insole, with the underlying mechanism as enhancing the mechanoreceptors on the plantar surface of the feet.

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Effect of Vitamin K2 on Postural Sway in Older People Who Fall: A Randomized Controlled Trial.

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Effect of Vitamin K2 on Postural Sway in Older People Who Fall: A Randomized Controlled Trial.

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