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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin K2 | Experimental | Vitamin K2 (menaquinone-7), 300µg/d, one capsule per day |
|
| Placebo Control | Placebo Comparator | Placebo with similar appearance and taste, one capsule per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin K2 | Dietary Supplement | Vitamin K2 (MK-7) 300µg/d for 1 year |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Handgrip strength | Handgrip strength was measured in participants using an electronic dynamometer. | Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measurements were recorded at 24 months (end of follow-up). |
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Inclusion Criteria:
Participants who meet all the following conditions will be included in the trial:
Exclusion Criteria:
Participants who meet any of the following conditions will be excluded from the trial:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China | ||
| Hongqi Hospital Affiliated to Mudanjiang Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20149620 | 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. | |
| 11911978 |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D024482 | Vitamin K 2 |
| ID | Term |
|---|---|
| D014812 | Vitamin K |
| D009285 | Naphthoquinones |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Placebo |
| Dietary Supplement |
Placebo for 1 year |
|
| 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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). | 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. | 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). | 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. | Measurements were taken at 0 (baseline),6, and 12 (end of intervention) months. |
| 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) | 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). | 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 | 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. | 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)). | 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). | 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)). | 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)). | 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)). | 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. | 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. | 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. | 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. | Measurements were taken at 3, 6, 9, 12 (end of intervention), and 24 (end of follow-up) months. |
| Mudanjiang |
| Heilongjiang |
| 157000 |
| China |
| The Second Affiliated Hospital of Qiqihar Medical University | Qiqihar | Heilongjiang | 161006 | China |
| Background |
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| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010836 | Phytol |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |