Clinical trial NCT06817512: Ischemic Stroke Nutrition Intervention Study
Official title: Health Effects of Vitamin K2 and Zinc Supplementation on Skeletal Muscle and Neurological Function After Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Keywords: Vitamin K2
Zinc
Skeletal Muscle
Neurological Function
Ischemic Stroke
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of this clinical trial is to assess whether vitamin K2 or zinc 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 or zinc improve the subjects' muscle strength and muscle mass? 2. Can supplementation with vitamin K2 or zinc improve the subjects' neurological function after a stroke? Researchers will compare vitamin K2 or zinc supplements with a placebo to observe whether vitamin K2 or zinc supplementation can improve skeletal muscle and neurological function in patients with ischemic stroke. Participants will: 1. Take vitamin K2 (MK-7), zinc supplements, or a placebo daily for 2 years. 2. Attend face-to-face visits and provide biological samples and relevant data at 0, 3, 6, 9, 12, and 24 months (intervention phase). After the intervention, follow-up will continue for 1 year to observe the long-term effects.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in handgrip strength
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
Secondary outcomes:
measure: Change in National Institute of Health Stroke Scale (NIHSS) score
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in Modified Rankin Scale (mRS) score
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in Mini-Mental State Examination (MMSE) score
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in ischemic lesion volume
timeFrame: At 0 (baseline), 12 and 24 months.
measure: Change in white matter lesions
timeFrame: At 0 (baseline), 12 and 24 months.
measure: Change in cerebral blood flow and function
timeFrame: At 0 (baseline), 12 and 24 months.
measure: Change in overall brain structural
timeFrame: At 0 (baseline), 12 and 24 months.
measure: Change in body composition
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in Fugl-Meyer Assessment (FMA) score
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in functional lower extremity strength
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in gait performance
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in carotid intima-media thickness (IMT)
timeFrame: At 0 (baseline), 6, 12, and 24 months.
measure: Change in carotid plaques
timeFrame: At 0 (baseline), 6, 12, and 24 months.
measure: Change in Brachial-ankle PWV (baPWV)
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in Ankle Brachial Index (ABI)
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in body weight
timeFrame: At 0 (baseline), 3, 6,9, 12, 24 and 36 months.
measure: Change in waist circumference
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in hip circumference
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in upper arm circumference
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in thigh circumference
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in calf circumference
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in blood pressure (systolic pressure and diastolic pressure)
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in heart rate
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in anxiety or depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS）
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Change in Quality of life measured by the 36-item Short Form Health Survey Questionnaire (SF-36)
timeFrame: At 0 (baseline), 3, 6, 9, 12, 24 and 36 months.
measure: Changes in vitamin K2 and zinc-related biomarkers
timeFrame: At 0 (baseline), 3, 6, 9,12 and 24 months.
measure: Changes in glycemic parameters
timeFrame: At 0 (baseline), 3, 6, 9,12 and 24 months.
measure: Changes in lipid metabolism parameters
timeFrame: At 0 (baseline), 3, 6, 9,12 and 24 months.
measure: Changes in inflammation-related indicators
timeFrame: At 0 (baseline), 3, 6, 9,12 and 24 months.
measure: Changes in muscle damage and cardiovascular health-related indicators
timeFrame: At 0 (baseline), 3, 6, 9,12 and 24 months.
measure: Changes in blood transcriptomics
timeFrame: At 0 (baseline), 3, 6, 9, 12 and 24 months.
measure: Changes in metabolomics in serum, urine, and feces
timeFrame: At 0 (baseline), 3, 6, 9,12, 24 months.
measure: Changes in the gut and oral microbiome
timeFrame: At 0 (baseline), 3, 6, 9,12 and 24 months.
measure: Occurrence of cardiovascular and cerebrovascular events
timeFrame: At 3, 6, 9,12, 24 and 36 months.
Other outcomes:
Locations:
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: Harbin Medical University
state: Heilongjiang
city: Mudanjiang
country: China
facility: Hongqi Hospital Affiliated to Mudanjiang Medical University
state: Heilongjiang
city: Qiqihar
country: China
facility: The Second Affiliated Hospital of Qiqihar Medical University
state: Heilongjiang
Study officials:
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