NCT07767214Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 11 Aug 2026
- Start date
- 1 Jan 2026
- Primary completion date
- 1 Feb 2028
- Lead sponsor
- Suzhou Municipal Hospital of Anhui Province
- Diseases
- Stroke
- NCT number
- NCT07767214
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 1 Jan 2026 to the primary completion date, 1 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- 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).
Other
- Severe Disability: Pre-morbid or current modified Rankin Scale (mRS) score \> 3.
- Participation: Participation in another interventional clinical trial within the past 30 days.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Suzhou Hospital Affiliated to Anhui Medical University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.