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Ischemic Stroke Nutrition Intervention Study

Plain-language guide to NCT06817512: not phased randomized trial of Vitamin D, K2, Magnesium and Zinc, 190 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06817512
Phase
not phased
Status
active, not recruiting
Start
2025-03-23
Completion (planned or actual)
2026-08-07
Participants
190 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Ischemic Stroke
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Vitamin D, K2, Magnesium and Zinc.

The main questions it aims to answer are: 1.

It had two arms (groups): Vitamin K2 (experimental) and Placebo Control (placebo comparator).

Placebo with similar appearance and taste, one capsule per day.

The registry classes the interventions as dietary supplement.

Who Took Part

Enrollment: 190 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men or women aged ≥ 18 years. The patient and their legal guardian (or legally acceptable representative) voluntarily sign the informed consent form.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: 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; coagulation dysfunction or use of vitamin k antagonists.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Vitamin D, K2, Magnesium and Zinc.

Those kept unaware of assignments: participant and investigator.

It started in 2025-03-23 with completion listed for 2026-08-07.

It ran at 3 sites in China (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Handgrip strength (time frame: Measurements were taken at 0 (baseline), 3, 6, and 12 (end of intervention) months).

It also tracked 36 secondary outcomes, for example Sustained effects of the intervention on handgrip strength, National Institute of Health Stroke Scale (NIHSS) score, Modified Rankin Scale (mRS) score, Mini-Mental State Examination (MMSE) score, Change in ischemic lesion volume and Change in white matter lesions.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 190 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.

Our Notes on the Compound

Vitamin D, K2, Magnesium and Zinc: Magnesium is described as required for AMPK to function.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.