vitamin K2
Dietary SupplementVitamin K2 (MK-7) 300µg/d for 1 year
NCT Number: NCT06817512
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
Vitamin K2 (MK-7) 300µg/d for 1 year
Placebo for 1 year
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Time frame: Measurements were taken at 0 (baseline), 3, 6, 12 (end of intervention), and 24 (end of follow-up) months.
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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)).
Time frame: 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).
Time frame: 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)).
Time frame: 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)).
Time frame: 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)).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Harbin Medical University
Other
Health Effects of Vitamin K2 Supplementation on Skeletal Muscle and Neurological Function After Ischemic Stroke
Acronym: ISNIS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06477016
Brain Diseases, Cardiovascular Diseases
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT06011720
Brain Diseases, Brain Ischemia
New Brunswick, New Jersey, United States
View Trial DetailsNCT04624646
Arrhythmias, Cardiac, Atrial Fibrillation
Yongin, Gyeonggi-do, South Korea
View Trial DetailsNCT05491980
Aneurysmal Subarachnoid Hemorrhage, Anoxic Brain Injury
Jacksonville, Florida, United States
View Trial Details