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A study on the health effects of Vitamin K2 and Zinc supplementation on skeletal muscle and neurological function in patients with ischemic stroke

A study on the health effects of Vitamin K2 and Zinc supplementation on skeletal muscle and neurological function in patients with ischemic stroke

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079734
Enrollment
Unknown
Registered
2024-01-10
Start date
2024-01-10
Completion date
Unknown
Last updated
2024-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischemic stroke

Interventions

control group:Placebo
VK2 group :vitamin k2
Zinc group:Zinc

Sponsors

Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) 40-70 years old; 2) Patients with new onset ischemic stroke within 7 days without previous significant limb paralysis, NIHSS score 5-15 and muscle strength level 2-4; 3) Sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1) presence of disturbance of consciousness, aphasia, or dysphagia; 2) diagnosed or suspected with cerebral hemorrhage, cardiogenic cerebral infarction, atrial fibrillation; 3) receiving thrombolytic therapy; 4) severe congestive heart failure, malignant hypertension, chronic gastrointestinal malabsorption (e.g., celiac disease, short bowel syndrome); significant hepatic and renal impairment; Persistent malignancy (continuous treatment, or diagnosis of malignancy less than 5 years); 5) suffered musculoskeletal disease or cognitive impairment prior to stroke; 6) a history of major surgery within the past year; Patients with previous total or subtotal thyroidectomy or current treatment with thyroid hormone or parathyroid hormone; 7) subjects have taken zinc, vitamin K2, or a vitamin K antagonist (e.g., warfarin) within 1 month before trial; 8) Currently on a fixed dose or with plans to use cognitive or neuro-improving drugs during the study, such as cholinesterase inhibitors, methoxamine, purines, vitamins (e.g., vitamin E, vitamin B series), and cephalomyelin; 9) patients with normal eating restriction or receiving enteral and parenteral nutrition support; 10) contraindications to MRI and other examinations; 11) Alcoholism; 12) currently pregnant or planning to become pregnant within the follow year; currently lactating; 13) participated in a clinical trial using the investigational drug or device within the past 3 months.

Design outcomes

Primary

MeasureTime frame
muscle strength;

Secondary

MeasureTime frame
body composition;serum vitamin k2;serum dp-ucMGP;ABI;baPWV;Head MRI;carotid artery ultrasound;serum Zinc;oral microbiome;Mini-Mental State Examination,MMSE;Hospital Anxiety and Depression Scale,HADS;Pittsburgh sleep quality index, PSQI;Fugl-Meyer assessment scale,FMA;Medical Outcomes Study 36-Item Short Form Health Survey,SF-36;serum biochemical indices;NIH Stroke Scale, NIHSS;Modified Rankin scale grade,MRSG;Exercise capacity testing;

Countries

China

Contacts

Public ContactLi Ying

Harbin Medical University

liying_helen@163.com+86 182 4513 2681

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026