Efficacy of Vitamin D in Post-Stroke Cognitive Impairment

Overview

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.

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.