Efficacy of Vitamin D in Post-Stroke Cognitive Impairment | NCT07767214 | Trialant

Active, not recruitingInterventionalNot ApplicableUpdated Aug 21, 2026

Efficacy of Vitamin D in Post-Stroke Cognitive Impairment

Efficacy and Immunological Mechanisms of Vitamin D Supplementation for Post-Stroke Cognitive Impairment: A Randomized Controlled Trial

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07767214
Lead Sponsor: Suzhou Municipal Hospital of Anhui ProvinceOTHER
Overall Status: Active, not recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 300Estimated
Last Update Posted: Aug 21, 2026Actual
Start Date: Jan 1, 2026Actual
Primary Completion Date: Feb 1, 2028Estimated
Completion Date: Jun 1, 2028Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Efficacy and Immunological Mechanisms of Vitamin D Supplementation for Post-Stroke Cognitive Impairment: A Randomized Controlled Trial
Brief Summary: Post-stroke cognitive impairment (PSCI) is a prevalent and debilitating sequela of stroke, posing a significant burden on patients and healthcare systems. Emerging evidence suggests that Vitamin D deficiency is associated with an increased risk of cognitive decline and neuroinflammation. However, the therapeutic potential and underlying immunological mechanisms of Vitamin D supplementation in PSCI remain unclear.

This study is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy of Vitamin D supplementation in improving cognitive function among patients with PSCI. The primary objective is to determine whether high-dose Vitamin D administration can significantly enhance cognitive performance compared to a placebo group. Secondary objectives include assessing the effects on serum inflammatory markers (such as IL-6, TNF-α, and IL-10) and regulatory T cells (Tregs), thereby exploring the potential immune-modulatory pathways.

Eligible participants will be randomly assigned to receive either oral Vitamin D (e.g., 5000 IU/day) or an identical placebo for a duration of [e.g., 6 months]. Cognitive function will be assessed using standardized neuropsychological tests, including the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE). Blood samples will be collected at baseline and post-intervention to measure changes in immune-related biomarkers.

The findings of this trial will provide critical evidence regarding the role of Vitamin D as a potential adjunctive therapy for PSCI and elucidate the connection between vitamin D status and post-stroke immune regulation.

Conditions

The medical conditions and diseases this study investigates.

Post-Stroke Cognitive Impairment (PSCI)

Interventions

The treatments and procedures being evaluated in this study.

Vitamin D2 capsules
Placebo Soft Capsules (Vitamin D₂-matched placebo)

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Age: Aged 18 to 80 years (inclusive).

Diagnosis: First-ever ischemic or hemorrhagic stroke, confirmed by brain CT or MRI within 1 week of onset.

Time Window: Post-stroke duration between 3 months and 24 months.

Cognitive Status: Presence of cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score < 26 (or your specific cutoff) at screening.

Stability: Clinically stable condition, without recurrent stroke or transient ischemic attack (TIA) in the past 3 months.

Consent: Ability to provide written informed consent by the participant or their legal representative.

Compliance: Willingness and ability to comply with the study protocol and follow-up visits.

Exclusion Criteria:

Severe Disability: Pre-morbid or current modified Rankin Scale (mRS) score > 3.

Other CNS Diseases: Presence of other neurological diseases that could cause cognitive decline (e.g., Parkinson's disease, epilepsy, brain tumor, or severe traumatic brain injury).

Psychiatric Disorders: History of major psychiatric disorders (e.g., schizophrenia, severe depression) that may interfere with cognitive testing.

Vitamin D Status: Known history of hypercalcemia, hypercalciuria, or sarcoidosis; or current use of vitamin D supplements (>800 IU/day) or calcium supplements within the past 3 months.

Severe Comorbidities: Severe dysfunction of heart, liver, or kidney (e.g., ALT/AST > 3x ULN, eGFR < 30 mL/min/1.73m²).

Life Expectancy: Life expectancy less than 6 months due to malignant tumors or other terminal illnesses.

Allergy: Known allergy or hypersensitivity to vitamin D or any components of the study formulation.

Participation: Participation in another interventional clinical trial within the past 30 days.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts

The people to reach with questions about this study or how to join it.

No central contacts

There are no central contacts for this study.

Locations

Where the study is run and whether each site is currently recruiting.

Suzhou Hospital Affiliated to Anhui Medical University

Suzhou, Anhui 234000, China

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Suzhou Municipal Hospital of Anhui ProvinceOTHER

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Other registered studies that closely resemble this one.

Detailed Description

Background and Rationale:

Post-stroke cognitive impairment (PSCI) is a prevalent complication that severely impacts patient rehabilitation and quality of life. Recent studies suggest that Vitamin D deficiency is highly prevalent in stroke patients and is closely associated with neuroinflammation and cognitive decline. However, high-quality clinical evidence regarding the efficacy of Vitamin D supplementation in PSCI and its underlying immunological mechanisms remains limited. This study aims to bridge this gap by providing clinical and mechanistic evidence.

Study Design and Participants:

This is a prospective, randomized, double-blind, placebo-controlled clinical trial. Eligible participants are adult patients diagnosed with acute ischemic stroke complicated by cognitive impairment within 7 days of onset. Patients with severe hepatic or renal dysfunction, or those already receiving high-dose Vitamin D therapy, will be excluded.

Intervention:

Eligible participants will be randomly assigned (1:1) to either the intervention group or the control group.

Intervention Group: Will receive oral Vitamin D2 capsules (5000 IU/day) for 6 months.

Control Group: Will receive identical placebo capsules for 6 months. Both patients and investigators will be blinded to the group assignments.

Outcome Assessments:

Primary Outcome: Changes in cognitive function from baseline to 6 months, assessed using the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE).

Secondary Outcomes: Changes in serum immune-inflammatory markers, including IL-6, TNF-α, IL-10, and the proportion of regulatory T cells (Tregs), measured via ELISA and flow cytometry at baseline and 6 months.

Sample Size and Statistical Analysis:

Based on a power calculation considering a 20% dropout rate, a total of 300 participants will be enrolled. All statistical analyses will be performed using SPSS software. Continuous variables will be compared using t-tests or Mann-Whitney U tests, while categorical variables will be analyzed using Chi-square tests. A p-value < 0.05 will be considered statistically significant.