Skip to content

A Research of the genetic-neural mechanisms and vitamin D intervention in cerebral small vessel disease: a prospective, non-random, and open label single-center study

A Research of the genetic-neural mechanisms and vitamin D intervention in cerebral small vessel disease: a prospective, non-random, and open label single-center study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068710
Enrollment
Unknown
Registered
2023-02-28
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral small vessel disease

Interventions

low-level vitamin D cerebral small vessel disease group:oral vitamin D drops or capsules with a therapeutic dose of 800iu BID for 12 months
normal-level vitamin D cerebral small vessel disease group:conventional antihypertensive, hypoglycemic, lipid-lowering drugs are given as needed
Control group:conventional antihypertensive, hypoglycemic, lipid-lowering drugs are given as needed

Sponsors

First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: Cerebral small vessel disease group: (1) aged 50–80 years, right-handed; (2) accompanied by at least one vascular risk factor (such as hypertension, diabetes, hyperlipidemia, and so on); (3) objective evidence of cognitive impairment in one or more domains; (4) met at least one imaging criteria: number of lacunar infarction =1; 3 scores for periventricular white matter hyperintensities or 2-3 scores for deep white matter hyperintensities, according to Fazekas rating scales; number of cerebral microbleeds =1 or moderate to severe dilated perivascular space (>10); (5) completed the cognitive evaluation and magnetic resonance imaging scanning involved in the study; (6) provided written informed consent by all participants or their relatives; (7) did not take vitamin D or any other drugs that may affect cognitive function 1 month before the experiment. Healthy controls: At the same time, healthy controls with matched characteristics of age, sex, and education were enrolled, who did not take vitamin D or any other drugs that may affect cognitive function 1 month before the experiment.

Exclusion criteria

Exclusion criteria: (1) history of brain tumor, traumatic injury, or intracranial operation; (2) cerebral hemorrhage, large area cerebral infarction, or cerebrovascular stenosis; (3) history of aging-related diseases that cause cognitive impairment such as Parkinson's disease, Alzheimer's disease, or Lewy body dementia; (4) severe visuospatial deficits, hearing impairments, or language disorders; (5) major neurological or psychiatric illness or drug/alcohol use disorder; (6) liver, kidney, heart, and lung dysfunction or systemic malignant tumors; and (7) contraindications of magnetic resonance imaging scanning, such as in-vivo dentures, metallic stents or pacemakers.

Design outcomes

Primary

MeasureTime frame
Neuropsychological assessment;

Secondary

MeasureTime frame
multimodal magnetic resonance imaging metrics;

Countries

China

Contacts

Public ContactSun Zhongwu

First Affiliated Hospital of Anhui Medical University

sunzhwu@126.com+86 13805515857

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026