NCT07767214Fut, nem toboroz
Efficacy of Vitamin D in Post-Stroke Cognitive Impairment
Efficacy and Immunological Mechanisms of Vitamin D Supplementation for Post-Stroke Cognitive Impairment: A Randomized Controlled Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 21.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 300 (tervezett)
- Első benyújtás
- 2026. aug. 11.
- Kezdés
- 2026. jan. 1.
- Elsődleges befejezés
- 2028. febr. 1.
- Fő szponzor
- Suzhou Municipal Hospital of Anhui Province
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT07767214
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 300
- 2026. jan. 1. és az elsődleges befejezés (2028. febr. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- 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.
- 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.
Laborértékek
- 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).
Egyéb
- Severe Disability: Pre-morbid or current modified Rankin Scale (mRS) score > 3.
- Participation: Participation in another interventional clinical trial within the past 30 days.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 40 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Suzhou Hospital Affiliated to Anhui Medical University | Suzhou | Kína | Ismeretlen állapot |
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