Ischemic Stroke
Conditions
Keywords
Vitamin K2, Skeletal Muscle, Neurological Function, Ischemic Stroke
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTVitamin K2
Vitamin K2 (MK-7) 300µg/d for 1 year
DIETARY_SUPPLEMENTPlacebo
Placebo for 1 year
Sponsors
Harbin Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip strength | Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months. | Handgrip strength was measured in participants using an electronic dynamometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained effects of the intervention on handgrip strength | Measurements were recorded at 24 months (end of follow-up). | 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. |
| National Institute of Health Stroke Scale (NIHSS) score | Measurements were taken at 0 (baseline), 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months. | 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). |
| Modified Rankin Scale (mRS) score | Measurements were taken at 0 (baseline), 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months. | 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. |
| Mini-Mental State Examination (MMSE) score | Measurements were taken at 0 (baseline), 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months. | 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. |
| Change in ischemic lesion volume | Measurements were taken at 0 (baseline) and 12 (end of intervention) months. | 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. |
| Change in white matter lesions | Measurements were taken at 0 (baseline) and 12 (end of intervention) months. | The progression of white matter lesions (especially in high-signal white matter and lesion expansion) will be detected through head MRI. |
| Change in cerebral blood flow and function | Measurements were taken at 0 (baseline) and 12 (end of intervention) months. | Cerebral blood flow and function (arterial blood supply and other ischemia-related imaging features) will be detected through head MRI. |
| Change in overall brain structural | Measurements were taken at 0 (baseline) and 12 (end of intervention) months. | The overall brain structural changes (brain atrophy and ventricular enlargement) will be detected through head MRI. |
| Body composition | Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months. | The body composition of patients will be measured using bioelectrical impedance analysis (BIA). |
| Fugl-Meyer Assessment (FMA) score | Measurements were taken at 0 (baseline), 3, 6,12 (end of intervention), and 24 (end of follow-up) months. | 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. |
| Functional lower extremity strength | Measurements were taken at 0 (baseline), 3, 6,12 (end of intervention), and 24 (end of follow-up) months. | The functional lower extremity strength of patients will be evaluated through the 30-second Chair Stand Test (CST). |
| Gait performance | Measurements were taken at 0 (baseline), 3, 6,12 (end of intervention), and 24 (end of follow-up) months. | The gait performance of patients will be measured using 6-meter walk tests. |
| Carotid intima-media thickness (IMT) | Measurements were taken at 0 (baseline),6, and 12 (end of intervention) months. | The patients will receive carotid artery ultrasonography to quantify carotid intima-media thickness (IMT). |
| Carotid plaques | Measurements were taken at 0 (baseline),6, and 12 (end of intervention) months. | The patients will undergo carotid artery ultrasonography to detect changes in carotid plaques. |
| Brachial-ankle PWV (baPWV) | Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months. | — |
| Ankle Brachial Index (ABI) | Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months. | — |
| Body weight | Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months. | — |
| Waist circumference | Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months. | — |
| Hip circumference | Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months. | — |
| Upper arm circumference | Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months. | — |
| Thigh circumference | Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months. | — |
| Calf circumference | 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) | Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months. | — |
| Heart rate | 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） | Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months. | 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). |
| Pittsburgh Sleep Quality Index (PSQI) | Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months. | 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 |
| Life quality | Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months. | 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. |
| Vitamin K2-related biomarkers | Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months. | 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)). |
| Glycemic parameters | Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months. | Blood samples from the patients will be tested for glycemic parameters (e.g., fasting blood glucose, fasting insulin). |
| Lipid metabolism parameters | Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months. | 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)). |
| Inflammation-related indicators | Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months. | 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)). |
| Muscle damage and cardiovascular health-related indicators | Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months. | Blood samples from the patients will be tested for muscle damage and cardiovascular health indicators (e.g., creatine kinase (CK) and myoglobin (Mb)). |
| Blood transcriptomics | Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months. | Transcriptomic sequencing will be performed on blood samples collected from the patients to observe changes in blood transcriptional levels. |
| Metabolomics in serum, urine, and feces | Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months. | Metabolomic sequencing will be performed on serum, urine, and fecal samples collected from the patients to observe changes in metabolic levels. |
| Gut and oral microbiome | Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months. | Microbiome sequencing will be conducted on fecal and saliva samples collected from the patients. |
| Occurrence of cardiovascular and cerebrovascular events | Measurements were taken at 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months. | Cardiovascular and cerebrovascular events of the patients will be monitored during the follow-up. |
Countries
China
Outcome results
None listed