Efficacy of Vitamin D in Post-Stroke Cognitive Impairment (ViD-PSCI)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Anhui
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Suzhou, Anhui, 중국, 234000
- Suzhou Hospital Affiliated to Anhui Medical University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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. |
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.
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위약 비교기: 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. |
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Montreal Cognitive Assessment (MoCA) Score
기간: 6 months
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The change in Montreal Cognitive Assessment (MoCA) score from baseline to 6 months post-randomization.
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6 months
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Change in Regulatory T Cells (Tregs) Proportion
기간: 6 months
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The change in the proportion of peripheral blood regulatory T cells (Tregs) from baseline to 6 months post-randomization, assessed via flow cytometry.
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Serum Inflammatory Markers
기간: 6 months
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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.
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6 months
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Change in Serum 25-Hydroxyvitamin D Level
기간: 6 months
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The change in serum 25-hydroxyvitamin D [25(OH)D] concentration from baseline to 6 months post-randomization.
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6 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AHMU-SZNE-2026-001
- 2025byzd011 (기타 보조금/기금 번호: Bengbu Medical University)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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