Nutrition intervention for improving recovery after ischemic stroke

Health Effects of Vitamin K2 and Zinc Supplementation on Skeletal Muscle and Neurological Function After Ischemic Stroke

This study is testing whether taking vitamin K2 and zinc can help people recover better from an ischemic stroke by improving their muscle strength and brain function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Harbin Medical University (Academic / other)
• Locations: 4 sites (Harbin, Heilongjiang and 3 other locations)
• Trial ID: NCT06817512 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of vitamin K2 and zinc supplementation on skeletal muscle and neurological function in patients who have recently experienced an ischemic stroke. Participants will receive either vitamin K2, zinc, or a placebo daily for two years, with regular assessments of muscle strength, muscle mass, and neurological function. The study aims to determine if these supplements can enhance recovery and improve overall health outcomes for stroke patients. Follow-up will continue for an additional year to evaluate long-term effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced a recent ischemic stroke without significant residual limb paralysis.

Not a fit: Patients with consciousness disorders, severe swallowing difficulties, or those diagnosed with cerebral hemorrhage will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved recovery and quality of life for patients who have suffered an ischemic stroke.

How similar studies have performed: While the specific combination of vitamin K2 and zinc for stroke recovery is novel, previous studies have shown that nutritional interventions can positively impact recovery in stroke patients.

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.

Where this trial is running

Harbin, Heilongjiang and 3 other locations

• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
• Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
• Hongqi Hospital Affiliated to Mudanjiang Medical University — Mudanjiang, Heilongjiang, China (Recruiting)
• The Second Affiliated Hospital of Qiqihar Medical University — Qiqihar, Heilongjiang, China (Recruiting)

Study contacts

• Study coordinator: Bin B Li, PhD

Conditions Ischemic Stroke; Vitamin K2; Zinc; Skeletal Muscle; Neurological Function