Efficacy and Immunological Mechanisms of Vitamin D Supplementation for Post-Stroke Cognitive Impairment: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in Montreal Cognitive Assessment (MoCA) Score
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Severe Disability: Pre-morbid or current modified Rankin Scale (mRS) score >
- •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.
研究组 & 干预措施
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.
干预措施: Vitamin D2 capsules (Dietary Supplement)
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.
干预措施: Placebo Soft Capsules (Vitamin D₂-matched placebo) (Dietary Supplement)
结局指标
主要结局
Change in Montreal Cognitive Assessment (MoCA) Score
时间窗: 6 months
The change in Montreal Cognitive Assessment (MoCA) score from baseline to 6 months post-randomization.
Change in Regulatory T Cells (Tregs) Proportion
时间窗: 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.
次要结局
- Change in Serum Inflammatory Markers(6 months)
- Change in Serum 25-Hydroxyvitamin D Level(6 months)