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NCT06817512Active, not recruiting

Ischemic Stroke Nutrition Intervention Study

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

Source: ClinicalTrials.gov · Last updated 8 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
190 (actual)
First submitted
14 Jan 2025
Start date
23 Mar 2025
Primary completion date
7 Aug 2026
Lead sponsor
Harbin Medical University
Diseases
Stroke
NCT number
NCT06817512

What you commit to

  • Study type: Interventional
  • Participants enrolled: 190
  • From 23 Mar 2025 to the primary completion date, 7 Aug 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently using or planning to use non research approved dietary supplements during the study period.
  • Currently using or planning to use drugs that affect cognitive or neurological function during the research period.
  • Restricted normal eating or currently receiving enteral or parenteral nutrition support.
  • Participated in a clinical trial using experimental drugs or devices within the past 3 months.

Other illness

  • Participants who meet any of the following conditions will be excluded from the trial:
  • Presence of consciousness disorders, aphasia, or swallowing disorders.
  • The diagnosis or suspicion of cerebral hemorrhage, atrial fibrillation, or other factors leading to cardiogenic cerebral infarction.
  • Having musculoskeletal diseases or cognitive impairment before the stroke.

Age

  • 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.

Other

  • Coagulation dysfunction or use of vitamin K antagonists.
  • Contraindications for MRI and other examinations.
  • Currently pregnant or planning pregnancy, currently breastfeeding.

Who the study is looking for

  • Participants who meet all the following conditions will be included in the trial:
  • Men or women aged ≥ 18 years.
  • 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.
  • The patient and their legal guardian (or legally acceptable representative) voluntarily sign the informed consent form.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Harbin Medical University
Coordinator of this site? Confirm its status
HarbinChinaUnknown status
Hongqi Hospital Affiliated to Mudanjiang Medical University
Coordinator of this site? Confirm its status
MudanjiangChinaUnknown status
The Second Affiliated Hospital of Qiqihar Medical University
Coordinator of this site? Confirm its status
QiqiharChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.