Ischemic Stroke Nutrition Intervention Study

Last updated: March 25, 2025
Sponsor: Harbin Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Blood Clots

Occlusions

Thrombosis

Treatment

Zinc

Placebo

Vitamin K2

Clinical Study ID

NCT06817512
HMUIRB2024027
  • Ages > 18
  • All Genders

Study 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

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.

Study Design

Total Participants: 250
Treatment Group(s): 3
Primary Treatment: Zinc
Phase:
Study Start date:
March 23, 2025
Estimated Completion Date:
December 30, 2029

Connect with a study center

  • Harbin Medical University

    Harbin, Heilongjiang 150086
    China

    Active - Recruiting

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Active - Recruiting

  • Hongqi Hospital Affiliated to Mudanjiang Medical University

    Mudanjiang, Heilongjiang 157000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Qiqihar Medical University

    Qiqihar, Heilongjiang 161006
    China

    Active - Recruiting

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