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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Anhui
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Suzhou, Anhui, Kiina, 234000
- Suzhou Hospital Affiliated to Anhui Medical University
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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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Placebo Comparator: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Montreal Cognitive Assessment (MoCA) Score
Aikaikkuna: 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Serum Inflammatory Markers
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Aivoverenkiertohäiriöt
- Aivojen sairaudet
- Keskushermoston sairaudet
- Hermoston sairaudet
- Verisuonisairaudet
- Sydän-ja verisuonitaudit
- Mielenterveyshäiriöt
- Neurokognitiiviset häiriöt
- Kognitiohäiriöt
- Aivohalvaus
- Kognitiivinen toimintahäiriö
- Lipidit
- Polisykliset yhdisteet
- Steroidit
- Sulatettu rengasyhdisteet
- Kolestenes
- Kolstanit
- Sterolit
- D -vitamiini
- Sekosteroidit
- Kalvolipidit
- Ergokalsiferolit
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