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

20 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

300

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • China
    • Anhui
      • Suzhou, Anhui, China, 234000
        • Suzhou Hospital Affiliated to Anhui Medical University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Suplemento dietético: 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.
Comparador de Placebo: 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.
Suplemento dietético: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Montreal Cognitive Assessment (MoCA) Score
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Serum Inflammatory Markers
Prazo: 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
Prazo: 6 months
The change in serum 25-hydroxyvitamin D [25(OH)D] concentration from baseline to 6 months post-randomization.
6 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Suzhou Municipal Hospital of Anhui Province

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 2026

Conclusão Primária (Estimado)

1 de fevereiro de 2028

Conclusão do estudo (Estimado)

1 de junho de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

11 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de agosto de 2026

Primeira postagem (Real)

17 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • AHMU-SZNE-2026-001
  • 2025byzd011 (Número de outro subsídio/financiamento: Bengbu Medical University)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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