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Efficacy of Vitamin D in Post-Stroke Cognitive Impairment (ViD-PSCI)

2026年8月20日 更新者：Suzhou Municipal Hospital of Anhui Province

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

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

300

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • 中国
    • Anhui
      • Suzhou、Anhui、中国、234000
        • Suzhou Hospital Affiliated to Anhui Medical University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：Vitamin D Supplementation Group

Intervention Group:

Participants will receive oral Vitamin D2 (Ergocalciferol) soft capsules at a dosage of 5,000 IU once daily for a period of 6 months.
ダイエットサプリメント：Vitamin D2 capsules
Participants in the intervention group will receive oral soft capsules containing Vitamin D₂ (Ergocalciferol) 5000 IU, taken once every 5 days (one capsule per administration) for a period of 6 months. The active capsules are identical in appearance, packaging, and taste to the placebo capsules to maintain blinding.
プラセボコンパレーター：Placebo Group

Placebo Group:

Participants will receive oral placebo soft capsules that are identical in appearance, packaging, and taste to the Vitamin D2 capsules. The placebo will be administered once daily for a period of 6 months.
ダイエットサプリメント：Placebo Soft Capsules (Vitamin D₂-matched placebo)

Participants in the placebo group will receive oral soft capsules that are identical in appearance, color, size, taste, and packaging to the active Vitamin D₂ (5000 IU) capsules. The placebo capsules contain no active Vitamin D₂ ingredient and are filled with the same excipient matrix (e.g., refined vegetable oil / medium-chain triglycerides) as the active capsules, without added calcium or other active substances that could affect outcomes.

Administration: One capsule is taken orally once every 5 days (same dosing frequency as the intervention group).

Duration: The intervention period lasts 6 months (approximately 36 total doses, aligned with the active group on the same calendar schedule).

Blinding: The placebo capsules are identical in labeling, packaging, odor, and taste to the active capsules. A third-party will handle packaging and coding to maintain double-blinding among researchers, participants, and outcome assessors.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Montreal Cognitive Assessment (MoCA) Score
時間枠：6 months
The change in Montreal Cognitive Assessment (MoCA) score from baseline to 6 months post-randomization.
6 months
Change in Regulatory T Cells (Tregs) Proportion
時間枠：6 months
The change in the proportion of peripheral blood regulatory T cells (Tregs) from baseline to 6 months post-randomization, assessed via flow cytometry.
6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Serum Inflammatory Markers
時間枠：6 months
The change in serum levels of inflammatory markers, including Interleukin-6 (IL-6), Tumor Necrosis Factor-alpha (TNF-α), and Interleukin-10 (IL-10), from baseline to 6 months post-randomization.
6 months
Change in Serum 25-Hydroxyvitamin D Level
時間枠：6 months
The change in serum 25-hydroxyvitamin D [25(OH)D] concentration from baseline to 6 months post-randomization.
6 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Suzhou Municipal Hospital of Anhui Province

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月1日

一次修了 (推定)

2028年2月1日

研究の完了 (推定)

2028年6月1日

試験登録日

最初に提出

2026年8月11日

QC基準を満たした最初の提出物

2026年8月11日

最初の投稿 (実際)

2026年8月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月21日

QC基準を満たした最後の更新が送信されました

2026年8月20日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • AHMU-SZNE-2026-001
  • 2025byzd011 (その他の助成金/資金番号：Bengbu Medical University)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

No sharing is planned due to patient privacy and ethical committee restrictions.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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