Ischemic StrokeISNISNCT06817512

Ischemic Stroke Nutrition Intervention Study

A study testing Vitamin K2 in people with Ischemic Stroke, run by Harbin Medical University at 3 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Ischemic Stroke
What is being tested?: Vitamin K2
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 190 participants
Where: 3 sitesChina
Study dates: 23 Mar 2025to 1 Sep 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants who meet all the following conditions will be included in the trial:
Men or women aged ≥ 18 years.
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.
The patient and their legal guardian (or legally acceptable representative) voluntarily sign the informed consent form.

Who cannot join

Participants who meet any of the following conditions will be excluded from the trial:
Presence of consciousness disorders, aphasia, or swallowing disorders.
The diagnosis or suspicion of cerebral hemorrhage, atrial fibrillation, or other factors leading to cardiogenic cerebral infarction.
Coagulation dysfunction or use of vitamin K antagonists.
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.
Having musculoskeletal diseases or cognitive impairment before the stroke.

Show all 12Show fewer

Currently using or planning to use non research approved dietary supplements during the study period.
Currently using or planning to use drugs that affect cognitive or neurological function during the research period.
Restricted normal eating or currently receiving enteral or parenteral nutrition support.
Contraindications for MRI and other examinations.
Currently pregnant or planning pregnancy, currently breastfeeding.
Participated in a clinical trial using experimental drugs or devices within the past 3 months.

Trial locations and contacts

3 sites in 1 country.

China3 sites

The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Hongqi Hospital Affiliated to Mudanjiang Medical University
Mudanjiang, Heilongjiang, 157000
The Second Affiliated Hospital of Qiqihar Medical University
Qiqihar, Heilongjiang, 161006

Other trials in China

About this study

Official title: Health Effects of Vitamin K2 Supplementation on Skeletal Muscle and Neurological Function After Ischemic Stroke

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.

Conditions: Ischemic Stroke
Being tested: Vitamin K2, Placebo
Keywords: Vitamin K2, Skeletal Muscle, Neurological Function, Ischemic Stroke
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin K2Dietary supplement
Vitamin K2 (MK-7) 300µg/d for 1 year
PlaceboDietary supplement
Placebo for 1 year

Study groups in NCT06817512
Study group	Role	What they receive
Vitamin K2	Experimental	Vitamin K2 (menaquinone-7), 300µg/d, one capsule per day Receives: Dietary Supplement: Vitamin K2
Placebo Control	Placebo comparator	Placebo with similar appearance and taste, one capsule per day Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Handgrip strength
Handgrip strength was measured in participants using an electronic dynamometer.
Measured: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.

Secondary outcomes (36)

Sustained effects of the intervention on handgrip strength
The change in handgrip strength from month 12 (end of intervention) to month 24 (end of follow-up) was assessed. This evaluation aimed to determine the sustained impact of the intervention on handgrip strength following the discontinuation of treatment.
Measured: Measurements were recorded at 24 months (end of follow-up).
National Institute of Health Stroke Scale (NIHSS) score
The severity of neurological deficits in participants was evaluated using the National Institutes of Health Stroke Scale (NIHSS). This scale provides a standardized assessment, with total scores ranging from 0 (indicating no deficit) to 42 (representing severe neurological injury).
Measured: Measurements were taken at 0 (baseline), 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months.
Modified Rankin Scale (mRS) score
The functional neurological recovery of participants will be assessed using the Modified Rankin Scale (mRS). This scale (0-6) quantifies post-stroke disability, where lower scores indicate better outcomes.
Measured: Measurements were taken at 0 (baseline), 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months.
Mini-Mental State Examination (MMSE) score
The Mini-Mental State Examination (MMSE) will be administered to patients to evaluate cognitive function across multiple domains using a validated 30-point scale (0, severe impairment; 30, intact cognition), with higher scores indicating better cognitive performance.
Measured: Measurements were taken at 0 (baseline), 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months.
Change in ischemic lesion volume
This study will assess changes in head MRI of patients with ischemic stroke. Change in ischemic lesion volume includes enlargement or reduction of infarcts and the appearance of new ischemic lesions.
Measured: Measurements were taken at 0 (baseline) and 12 (end of intervention) months.
Change in white matter lesions
The progression of white matter lesions (especially in high-signal white matter and lesion expansion) will be detected through head MRI.
Measured: Measurements were taken at 0 (baseline) and 12 (end of intervention) months.
Change in cerebral blood flow and function
Cerebral blood flow and function (arterial blood supply and other ischemia-related imaging features) will be detected through head MRI.
Measured: Measurements were taken at 0 (baseline) and 12 (end of intervention) months.
Change in overall brain structural
The overall brain structural changes (brain atrophy and ventricular enlargement) will be detected through head MRI.
Measured: Measurements were taken at 0 (baseline) and 12 (end of intervention) months.
Body composition
The body composition of patients will be measured using bioelectrical impedance analysis (BIA).
Measured: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Fugl-Meyer Assessment (FMA) score
The Fugl-Meyer Assessment (FMA) was employed to evaluate motor function in the patient's upper and lower limbs, with total scores ranging from 0 to 100, where higher scores indicate better motor recovery.
Measured: Measurements were taken at 0 (baseline), 3, 6,12 (end of intervention), and 24 (end of follow-up) months.
Functional lower extremity strength
The functional lower extremity strength of patients will be evaluated through the 30-second Chair Stand Test (CST).
Measured: Measurements were taken at 0 (baseline), 3, 6,12 (end of intervention), and 24 (end of follow-up) months.
Gait performance
The gait performance of patients will be measured using 6-meter walk tests.
Measured: Measurements were taken at 0 (baseline), 3, 6,12 (end of intervention), and 24 (end of follow-up) months.
Carotid intima-media thickness (IMT)
The patients will receive carotid artery ultrasonography to quantify carotid intima-media thickness (IMT).
Measured: Measurements were taken at 0 (baseline),6, and 12 (end of intervention) months.
Carotid plaques
The patients will undergo carotid artery ultrasonography to detect changes in carotid plaques.
Measured: Measurements were taken at 0 (baseline),6, and 12 (end of intervention) months.
Brachial-ankle PWV (baPWV)
Measured: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Ankle Brachial Index (ABI)
Measured: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Body weight
Measured: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Waist circumference
Measured: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Hip circumference
Measured: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Upper arm circumference
Measured: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Thigh circumference
Measured: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Calf circumference
Measured: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Blood pressure (systolic pressure and diastolic pressure)
Measured: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Heart rate
Measured: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Hospital Anxiety and Depression Scale (HADS）
The Hospital Anxiety and Depression Scale (HADS) was administered to the patients, with the anxiety (HADS-A) and depression (HADS-D) subscales each yielding scores from 0 (asymptomatic) to 21 (severe symptoms).
Measured: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Pittsburgh Sleep Quality Index (PSQI)
The sleep quality of each patient will be evaluated by the Pittsburgh Sleep Quality Index (PSQI), with scores ranging from 0 to 21, with higher scores indicating poorer sleep quality
Measured: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Life quality
The SF-36 assesses 8 health domains (physical or mental function, pain, vitality, etc.) through 36 Likert-scale questions. Scores range from 0 (worst health) to 100 (best health) per domain.
Measured: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Vitamin K2-related biomarkers
Blood samples from the patients will be tested for biomarkers related to vitamin K2 (e.g., serum vitamin K2, dephosphorylated uncarboxylated matrix Gla-protein (dp-ucMGP)).
Measured: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Glycemic parameters
Blood samples from the patients will be tested for glycemic parameters (e.g., fasting blood glucose, fasting insulin).
Measured: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Lipid metabolism parameters
Blood samples from the patients will be tested for lipid metabolism parameters (e.g., serum total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)).
Measured: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Inflammation-related indicators
Blood samples from the patients will be tested for inflammation-related markers (e.g., IL-1β, IL-6, IL-8, IL-10, TNF-α, TGF-β, TNF-α-induced protein 3 (TNFAIP3), C-reactive protein (CRP)).
Measured: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Muscle damage and cardiovascular health-related indicators
Blood samples from the patients will be tested for muscle damage and cardiovascular health indicators (e.g., creatine kinase (CK) and myoglobin (Mb)).
Measured: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Blood transcriptomics
Transcriptomic sequencing will be performed on blood samples collected from the patients to observe changes in blood transcriptional levels.
Measured: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Metabolomics in serum, urine, and feces
Metabolomic sequencing will be performed on serum, urine, and fecal samples collected from the patients to observe changes in metabolic levels.
Measured: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Gut and oral microbiome
Microbiome sequencing will be conducted on fecal and saliva samples collected from the patients.
Measured: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Occurrence of cardiovascular and cerebrovascular events
Cardiovascular and cerebrovascular events of the patients will be monitored during the follow-up.
Measured: Measurements were taken at 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Mar 20251 Sep 2027

First posted10 Feb 2025
Study start23 Mar 2025
Primary completion7 Aug 2026
Study completion1 Sep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Ischemic StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 190 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06817512
Sponsor's protocol ID: HMUIRB2024027
Acronym: ISNIS
Status last verified: Sep 2026
First submitted: 14 Jan 2025
Last updated: 8 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 20149620
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.
PubMed 11911978
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.
PubMed 22290807
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.
PubMed 21084607
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.
PubMed 11282913
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.
PubMed 21653572
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.
PubMed 14704312
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.
PubMed 25538207
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.
PubMed 27648390
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.
PubMed 30514729
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.
PubMed 29617432
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.
PubMed 34472618
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.
PubMed 28254181
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.
PubMed 33888706
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.
PubMed 32396989

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Health Effects of Vitamin K2 Supplementation on Skeletal Muscle and Neurological Function After Ischemic Stroke
ClinicalTrials.gov ID: NCT06817512
Acronym / sponsor ID: ISNIS / HMUIRB2024027
Conditions: Ischemic Stroke
Keywords: Vitamin K2, Skeletal Muscle, Neurological Function, Ischemic Stroke
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 190 participants (actual)
Lead sponsor: Harbin Medical UniversityUniversity, hospital or other
Study start: 23 Mar 2025 (actual)
Primary completion: 7 Aug 2026 (actual)
Study completion: 1 Sep 2027 (estimated)
First posted: 10 Feb 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Vitamin K2	Experimental	Dietary Supplement: Vitamin K2Vitamin K2 (menaquinone-7), 300µg/d, one capsule per day
Placebo Control	Placebo comparator	Dietary Supplement: PlaceboPlacebo with similar appearance and taste, one capsule per day

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Men or women aged ≥ 18 years.
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.
The patient and their legal guardian (or legally acceptable representative) voluntarily sign the informed consent form.

Key exclusion criteria (12 listed)

Presence of consciousness disorders, aphasia, or swallowing disorders.
The diagnosis or suspicion of cerebral hemorrhage, atrial fibrillation, or other factors leading to cardiogenic cerebral infarction.
Coagulation dysfunction or use of vitamin K antagonists.
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.
Having musculoskeletal diseases or cognitive impairment before the stroke.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin K2Vitamin K2 (MK-7) 300µg/d for 1 year	Dietary supplement	Vitamin K2
PlaceboPlacebo for 1 year	Dietary supplement	Placebo Control

Primary outcome

Handgrip strength
Time frame: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Handgrip strength was measured in participants using an electronic dynamometer.

36 secondary outcomes

Sustained effects of the intervention on handgrip strength
Time frame: Measurements were recorded at 24 months (end of follow-up).
National Institute of Health Stroke Scale (NIHSS) score
Time frame: Measurements were taken at 0 (baseline), 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months.
Modified Rankin Scale (mRS) score
Time frame: Measurements were taken at 0 (baseline), 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months.
Mini-Mental State Examination (MMSE) score
Time frame: Measurements were taken at 0 (baseline), 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months.
Change in ischemic lesion volume
Time frame: Measurements were taken at 0 (baseline) and 12 (end of intervention) months.
Change in white matter lesions
Time frame: Measurements were taken at 0 (baseline) and 12 (end of intervention) months.
Change in cerebral blood flow and function
Time frame: Measurements were taken at 0 (baseline) and 12 (end of intervention) months.
Change in overall brain structural
Time frame: Measurements were taken at 0 (baseline) and 12 (end of intervention) months.
Body composition
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Fugl-Meyer Assessment (FMA) score
Time frame: Measurements were taken at 0 (baseline), 3, 6,12 (end of intervention), and 24 (end of follow-up) months.
Functional lower extremity strength
Time frame: Measurements were taken at 0 (baseline), 3, 6,12 (end of intervention), and 24 (end of follow-up) months.
Gait performance
Time frame: Measurements were taken at 0 (baseline), 3, 6,12 (end of intervention), and 24 (end of follow-up) months.
Carotid intima-media thickness (IMT)
Time frame: Measurements were taken at 0 (baseline),6, and 12 (end of intervention) months.
Carotid plaques
Time frame: Measurements were taken at 0 (baseline),6, and 12 (end of intervention) months.
Brachial-ankle PWV (baPWV)
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Ankle Brachial Index (ABI)
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Body weight
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Waist circumference
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Hip circumference
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Upper arm circumference
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Thigh circumference
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Calf circumference
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Blood pressure (systolic pressure and diastolic pressure)
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Heart rate
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Hospital Anxiety and Depression Scale (HADS）
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Life quality
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Vitamin K2-related biomarkers
Time frame: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Glycemic parameters
Time frame: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Lipid metabolism parameters
Time frame: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Inflammation-related indicators
Time frame: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Muscle damage and cardiovascular health-related indicators
Time frame: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Blood transcriptomics
Time frame: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Metabolomics in serum, urine, and feces
Time frame: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Gut and oral microbiome
Time frame: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
Occurrence of cardiovascular and cerebrovascular events
Time frame: Measurements were taken at 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
Background: PubMed 20149620Ohsaki 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.
Background: PubMed 11911978Tsang 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.
Background: PubMed 22290807Gely-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.
Background: PubMed 21084607Zhong 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.
Background: PubMed 11282913Shibata 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.
Background: PubMed 21653572Carrie 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.
Background: PubMed 14704312Carrie 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.
Background: PubMed 25538207Viegas 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.
Background: PubMed 27648390Harshman 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.
Background: PubMed 30514729Lees 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.
Background: PubMed 29617432Ronning 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.
Background: PubMed 34472618Mladenka 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin K2 in people with Ischemic Stroke, run by Harbin Medical University at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Handgrip strength (time frame: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06817512, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.