Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
190 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-03-23
Study Completion Date
2028-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The primary goal of this clinical trial is to assess whether vitamin K2 supplementation can effectively improve skeletal muscle and neurological function in patients with ischemic stroke. The main questions it aims to answer are: 1. Does supplementation with vitamin K2 improve the subjects' muscle strength and muscle mass? 2. Can supplementation with vitamin K2 improve the subjects' neurological function after a stroke? Researchers will compare vitamin K2 supplements with a placebo to observe whether vitamin K2 supplementation can improve skeletal muscle and neurological function in patients with ischemic stroke. Participants will: 1. Take vitamin K2 (MK-7) or a placebo daily for 1 year. 2. Attend face-to-face visits and provide biological samples and relevant data at 0, 3, 6, and 12 months. At 9 months, the visit will be online. After the intervention, follow-up will continue for 1 year to observe the long-term effects.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Ischemic Stroke
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Vitamin K2
Skeletal Muscle
Neurological Function
Ischemic Stroke
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vitamin K2
Vitamin K2 (menaquinone-7), 300µg/d, one capsule per day
Group Type
EXPERIMENTAL
Vitamin K2
Intervention Type
DIETARY_SUPPLEMENT
Vitamin K2 (MK-7) 300µg/d for 1 year
Placebo Control
Placebo with similar appearance and taste, one capsule per day
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DIETARY_SUPPLEMENT
Placebo for 1 year
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vitamin K2
Vitamin K2 (MK-7) 300µg/d for 1 year
Intervention Type
DIETARY_SUPPLEMENT
Placebo
Placebo for 1 year
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Participants who meet all the following conditions will be included in the trial:
1. Men or women aged ≥ 18 years.
2. Patients with recent ischemic stroke（first or recurrent stroke no more than 7 days before admission）without significant residual limb paralysis, NIHSS score between 2-15, and muscle strength graded 2-4.
3. The patient and their legal guardian (or legally acceptable representative) voluntarily sign the informed consent form.
1. Men or women aged ≥ 18 years.
2. Patients with recent ischemic stroke（first or recurrent stroke no more than 7 days before admission）without significant residual limb paralysis, NIHSS score between 2-15, and muscle strength graded 2-4.
3. The patient and their legal guardian (or legally acceptable representative) voluntarily sign the informed consent form.
Exclusion Criteria
Participants who meet any of the following conditions will be excluded from the trial:
1. Presence of consciousness disorders, aphasia, or swallowing disorders.
2. The diagnosis or suspicion of cerebral hemorrhage, atrial fibrillation, or other factors leading to cardiogenic cerebral infarction.
3. Coagulation dysfunction or use of vitamin K antagonists.
4. Suffering from chronic gastrointestinal malabsorption (such as celiac disease, short bowel syndrome), severe congestive heart failure, malignant hypertension, severe liver and kidney dysfunction, persistent malignant tumors (continuous treatment, or diagnosis of malignant tumors\<5 years), or other related diseases considered by researchers that seriously affect the patient's survival.
5. Having musculoskeletal diseases or cognitive impairment before the stroke.
6. Currently using or planning to use non research approved dietary supplements during the study period.
7. Currently using or planning to use drugs that affect cognitive or neurological function during the research period.
8. Restricted normal eating or currently receiving enteral or parenteral nutrition support.
9. Contraindications for MRI and other examinations.
10. Currently pregnant or planning pregnancy, currently breastfeeding.
11. Participated in a clinical trial using experimental drugs or devices within the past 3 months.
1. Presence of consciousness disorders, aphasia, or swallowing disorders.
2. The diagnosis or suspicion of cerebral hemorrhage, atrial fibrillation, or other factors leading to cardiogenic cerebral infarction.
3. Coagulation dysfunction or use of vitamin K antagonists.
4. Suffering from chronic gastrointestinal malabsorption (such as celiac disease, short bowel syndrome), severe congestive heart failure, malignant hypertension, severe liver and kidney dysfunction, persistent malignant tumors (continuous treatment, or diagnosis of malignant tumors\<5 years), or other related diseases considered by researchers that seriously affect the patient's survival.
5. Having musculoskeletal diseases or cognitive impairment before the stroke.
6. Currently using or planning to use non research approved dietary supplements during the study period.
7. Currently using or planning to use drugs that affect cognitive or neurological function during the research period.
8. Restricted normal eating or currently receiving enteral or parenteral nutrition support.
9. Contraindications for MRI and other examinations.
10. Currently pregnant or planning pregnancy, currently breastfeeding.
11. Participated in a clinical trial using experimental drugs or devices within the past 3 months.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Harbin Medical University
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ying Li
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Site Status
Hongqi Hospital Affiliated to Mudanjiang Medical University
Mudanjiang, Heilongjiang, China
Site Status
The Second Affiliated Hospital of Qiqihar Medical University
Qiqihar, Heilongjiang, China
Site Status
Countries
Review the countries where the study has at least one active or historical site.
China
References
Explore related publications, articles, or registry entries linked to this study.
Febbraio MA, Pedersen BK. Who would have thought - myokines two decades on. Nat Rev Endocrinol. 2020 Nov;16(11):619-620. doi: 10.1038/s41574-020-00408-7. No abstract available.
Reference Type
BACKGROUND
Sun Y, Zehr EP. Training-Induced Neural Plasticity and Strength Are Amplified After Stroke. Exerc Sport Sci Rev. 2019 Oct;47(4):223-229. doi: 10.1249/JES.0000000000000199.
Reference Type
BACKGROUND
de Freitas GB, Lourenco MV, De Felice FG. Protective actions of exercise-related FNDC5/Irisin in memory and Alzheimer's disease. J Neurochem. 2020 Dec;155(6):602-611. doi: 10.1111/jnc.15039. Epub 2020 Jun 2.
Reference Type
BACKGROUND
Droujinine IA, Meyer AS, Wang D, Udeshi ND, Hu Y, Rocco D, McMahon JA, Yang R, Guo J, Mu L, Carey DK, Svinkina T, Zeng R, Branon T, Tabatabai A, Bosch JA, Asara JM, Ting AY, Carr SA, McMahon AP, Perrimon N. Proteomics of protein trafficking by in vivo tissue-specific labeling. Nat Commun. 2021 Apr 22;12(1):2382. doi: 10.1038/s41467-021-22599-x.
Reference Type
BACKGROUND
Ohsaki Y, Shirakawa H, Miura A, Giriwono PE, Sato S, Ohashi A, Iribe M, Goto T, Komai M. Vitamin K suppresses the lipopolysaccharide-induced expression of inflammatory cytokines in cultured macrophage-like cells via the inhibition of the activation of nuclear factor kappaB through the repression of IKKalpha/beta phosphorylation. J Nutr Biochem. 2010 Nov;21(11):1120-6. doi: 10.1016/j.jnutbio.2009.09.011. Epub 2010 Feb 9.
Reference Type
BACKGROUND
Tsang CK, Kamei Y. Novel effect of vitamin K(1) (phylloquinone) and vitamin K(2) (menaquinone) on promoting nerve growth factor-mediated neurite outgrowth from PC12D cells. Neurosci Lett. 2002 Apr 19;323(1):9-12. doi: 10.1016/s0304-3940(01)02550-2.
Reference Type
BACKGROUND
Gely-Pernot A, Coronas V, Harnois T, Prestoz L, Mandairon N, Didier A, Berjeaud JM, Monvoisin A, Bourmeyster N, De Frutos PG, Philippe M, Benzakour O. An endogenous vitamin K-dependent mechanism regulates cell proliferation in the brain subventricular stem cell niche. Stem Cells. 2012 Apr;30(4):719-31. doi: 10.1002/stem.1045.
Reference Type
BACKGROUND
Zhong Z, Wang Y, Guo H, Sagare A, Fernandez JA, Bell RD, Barrett TM, Griffin JH, Freeman RS, Zlokovic BV. Protein S protects neurons from excitotoxic injury by activating the TAM receptor Tyro3-phosphatidylinositol 3-kinase-Akt pathway through its sex hormone-binding globulin-like region. J Neurosci. 2010 Nov 17;30(46):15521-34. doi: 10.1523/JNEUROSCI.4437-10.2010.
Reference Type
BACKGROUND
Shibata M, Kumar SR, Amar A, Fernandez JA, Hofman F, Griffin JH, Zlokovic BV. Anti-inflammatory, antithrombotic, and neuroprotective effects of activated protein C in a murine model of focal ischemic stroke. Circulation. 2001 Apr 3;103(13):1799-805. doi: 10.1161/01.cir.103.13.1799.
Reference Type
BACKGROUND
Carrie I, Belanger E, Portoukalian J, Rochford J, Ferland G. Lifelong low-phylloquinone intake is associated with cognitive impairments in old rats. J Nutr. 2011 Aug;141(8):1495-501. doi: 10.3945/jn.110.137638. Epub 2011 Jun 8.
Reference Type
BACKGROUND
Carrie I, Portoukalian J, Vicaretti R, Rochford J, Potvin S, Ferland G. Menaquinone-4 concentration is correlated with sphingolipid concentrations in rat brain. J Nutr. 2004 Jan;134(1):167-72. doi: 10.1093/jn/134.1.167.
Reference Type
BACKGROUND
Viegas CS, Rafael MS, Enriquez JL, Teixeira A, Vitorino R, Luis IM, Costa RM, Santos S, Cavaco S, Neves J, Macedo AL, Willems BA, Vermeer C, Simes DC. Gla-rich protein acts as a calcification inhibitor in the human cardiovascular system. Arterioscler Thromb Vasc Biol. 2015 Feb;35(2):399-408. doi: 10.1161/ATVBAHA.114.304823. Epub 2014 Dec 23.
Reference Type
BACKGROUND
Harshman SG, Shea MK. The Role of Vitamin K in Chronic Aging Diseases: Inflammation, Cardiovascular Disease, and Osteoarthritis. Curr Nutr Rep. 2016 Jun;5(2):90-98. doi: 10.1007/s13668-016-0162-x. Epub 2016 Mar 31.
Reference Type
BACKGROUND
Lees JS, Chapman FA, Witham MD, Jardine AG, Mark PB. Vitamin K status, supplementation and vascular disease: a systematic review and meta-analysis. Heart. 2019 Jun;105(12):938-945. doi: 10.1136/heartjnl-2018-313955. Epub 2018 Dec 4.
Reference Type
BACKGROUND
Ronning SB, Pedersen ME, Berg RS, Kirkhus B, Rodbotten R. Vitamin K2 improves proliferation and migration of bovine skeletal muscle cells in vitro. PLoS One. 2018 Apr 4;13(4):e0195432. doi: 10.1371/journal.pone.0195432. eCollection 2018.
Reference Type
BACKGROUND
Mladenka P, Macakova K, Kujovska Krcmova L, Javorska L, Mrstna K, Carazo A, Protti M, Remiao F, Novakova L; OEMONOM researchers and collaborators. Vitamin K - sources, physiological role, kinetics, deficiency, detection, therapeutic use, and toxicity. Nutr Rev. 2022 Mar 10;80(4):677-698. doi: 10.1093/nutrit/nuab061.
Reference Type
BACKGROUND
Freeman AM, Morris PB, Barnard N, Esselstyn CB, Ros E, Agatston A, Devries S, O'Keefe J, Miller M, Ornish D, Williams K, Kris-Etherton P. Trending Cardiovascular Nutrition Controversies. J Am Coll Cardiol. 2017 Mar 7;69(9):1172-1187. doi: 10.1016/j.jacc.2016.10.086.
Reference Type
BACKGROUND
Park JG, Lee KW, Kim SB, Lee JH, Kim YH. Effect of Decreased Skeletal Muscle Index and Hand Grip Strength on Functional Recovery in Subacute Ambulatory Stroke Patients. Ann Rehabil Med. 2019 Oct;43(5):535-543. doi: 10.5535/arm.2019.43.5.535. Epub 2019 Oct 31.
Reference Type
BACKGROUND
Jones TA. Motor compensation and its effects on neural reorganization after stroke. Nat Rev Neurosci. 2017 May;18(5):267-280. doi: 10.1038/nrn.2017.26. Epub 2017 Mar 23.
Reference Type
BACKGROUND
Madureira S, Guerreiro M, Ferro JM. Dementia and cognitive impairment three months after stroke. Eur J Neurol. 2001 Nov;8(6):621-7. doi: 10.1046/j.1468-1331.2001.00332.x.
Reference Type
BACKGROUND
Guo J, Wang J, Sun W, Liu X. The advances of post-stroke depression: 2021 update. J Neurol. 2022 Mar;269(3):1236-1249. doi: 10.1007/s00415-021-10597-4. Epub 2021 May 30.
Reference Type
BACKGROUND
Wechsler LR, Adeoye O, Alemseged F, Bahr-Hosseini M, Deljkich E, Favilla C, Fisher M, Grotta J, Hill MD, Kamel H, Khatri P, Lyden P, Mirza M, Nguyen TN, Samaniego E, Schwamm L, Selim M, Silva G, Yavagal DR, Yenari MA, Zachrison KS, Boltze J, Yaghi S; XIIth Stroke Treatment Academic Industry Roundtable. Most Promising Approaches to Improve Stroke Outcomes: The Stroke Treatment Academic Industry Roundtable XII Workshop. Stroke. 2023 Dec;54(12):3202-3213. doi: 10.1161/STROKEAHA.123.044279. Epub 2023 Oct 27.
Reference Type
BACKGROUND
Tu WJ, Zhao Z, Yin P, Cao L, Zeng J, Chen H, Fan D, Fang Q, Gao P, Gu Y, Tan G, Han J, He L, Hu B, Hua Y, Kang D, Li H, Liu J, Liu Y, Lou M, Luo B, Pan S, Peng B, Ren L, Wang L, Wu J, Xu Y, Xu Y, Yang Y, Zhang M, Zhang S, Zhu L, Zhu Y, Li Z, Chu L, An X, Wang L, Yin M, Li M, Yin L, Yan W, Li C, Tang J, Zhou M, Wang L. Estimated Burden of Stroke in China in 2020. JAMA Netw Open. 2023 Mar 1;6(3):e231455. doi: 10.1001/jamanetworkopen.2023.1455.
Reference Type
BACKGROUND
Hu S, Cui B, Mlynash M, Zhang X, Mehta KM, Lansberg MG. Stroke epidemiology and stroke policies in China from 1980 to 2017: A systematic review and meta-analysis. Int J Stroke. 2020 Jan;15(1):18-28. doi: 10.1177/1747493019873562. Epub 2019 Sep 22.
Reference Type
BACKGROUND
Wang YJ, Li ZX, Gu HQ, Zhai Y, Zhou Q, Jiang Y, Zhao XQ, Wang YL, Yang X, Wang CJ, Meng X, Li H, Liu LP, Jing J, Wu J, Xu AD, Dong Q, Wang D, Wang WZ, Ma XD, Zhao JZ; China Stroke Statistics Writing Committee. China Stroke Statistics: an update on the 2019 report from the National Center for Healthcare Quality Management in Neurological Diseases, China National Clinical Research Center for Neurological Diseases, the Chinese Stroke Association, National Center for Chronic and Non-communicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention and Institute for Global Neuroscience and Stroke Collaborations. Stroke Vasc Neurol. 2022 Oct;7(5):415-450. doi: 10.1136/svn-2021-001374. Epub 2022 Apr 20.
Reference Type
BACKGROUND
Wang L, Zhou B, Zhao Z, Yang L, Zhang M, Jiang Y, Li Y, Zhou M, Wang L, Huang Z, Zhang X, Zhao L, Yu D, Li C, Ezzati M, Chen Z, Wu J, Ding G, Li X. Body-mass index and obesity in urban and rural China: findings from consecutive nationally representative surveys during 2004-18. Lancet. 2021 Jul 3;398(10294):53-63. doi: 10.1016/S0140-6736(21)00798-4.
Reference Type
BACKGROUND
Wang L, Peng W, Zhao Z, Zhang M, Shi Z, Song Z, Zhang X, Li C, Huang Z, Sun X, Wang L, Zhou M, Wu J, Wang Y. Prevalence and Treatment of Diabetes in China, 2013-2018. JAMA. 2021 Dec 28;326(24):2498-2506. doi: 10.1001/jama.2021.22208.
Reference Type
BACKGROUND
Owolabi MO, Thrift AG, Mahal A, Ishida M, Martins S, Johnson WD, Pandian J, Abd-Allah F, Yaria J, Phan HT, Roth G, Gall SL, Beare R, Phan TG, Mikulik R, Akinyemi RO, Norrving B, Brainin M, Feigin VL; Stroke Experts Collaboration Group. Primary stroke prevention worldwide: translating evidence into action. Lancet Public Health. 2022 Jan;7(1):e74-e85. doi: 10.1016/S2468-2667(21)00230-9. Epub 2021 Oct 29.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HMUIRB2024027
Identifier Type: -
Identifier Source: org_study_id