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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
190
Vitamin K2 (MK-7) 300µg/d for 1 year
Placebo for 1 year
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Hongqi Hospital Affiliated to Mudanjiang Medical University
Mudanjiang, Heilongjiang, China
The Second Affiliated Hospital of Qiqihar Medical University
Qiqihar, Heilongjiang, China
Handgrip strength
Handgrip strength was measured in participants using an electronic dynamometer.
Time frame: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months.
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.
Time frame: 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).
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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
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.
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
The functional lower extremity strength of patients will be evaluated through the 30-second Chair Stand Test (CST).
Time frame: 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.
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)
The patients will receive carotid artery ultrasonography to quantify carotid intima-media thickness (IMT).
Time frame: 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.
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）
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).
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)
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
Time frame: 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.
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
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)).
Time frame: 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).
Time frame: 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)).
Time frame: 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)).
Time frame: 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)).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measurements were taken at 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months.
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