Clinical trial NCT06539260: Clinical Relationship Between Vitamin D-mediated Th17 and Treg Cells and Parkinson's Disease
Official title: Clinical Relationship Between Vitamin D-mediated Th17 and Treg Cells and Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Neurology
Immunology
Keywords: Parkinson's disease
Vitamin D
Treg
Th17
Lead sponsor: Suzhou Municipal Hospital of Anhui Province
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to detect the expression levels of vitamin D, Treg, and Th17 in the peripheral blood of patients with Parkinson\&amp;#39;s disease (PD), investigate the impact of Treg/Th17 imbalance on PD patients, and explore the effects of vitamin D intervention on Treg/Th17 imbalance and clinical outcomes. Furthermore, this study aims to delve into the potential mechanisms of vitamin D deficiency and Treg/Th17 imbalance in the pathogenesis of Parkinson\&amp;#39;s disease, ultimately providing new theoretical evidence for the research, prevention, and treatment of PD.

Detailed description: FromJanuary 2023 to July 2024, 50 PD patients and 50 health control groups were collected. All subjects were from the Parkinson\&#39;s outpatient clinic and ward of the Department of Neurology, Suzhou Hospital Affiliated to Anhui Medical University. This study was approved by the Medical Ethics Committee of Suzhou Municipal Hospital and signed an informed consent form. The gender, age, identity registration, place of origin, marital status, education level, occupation, smoking, drinking, occupational exposure, body mass index, home address and contact information of the patients were collected for detailed registration. Current medical history, past history, family history, medication use, physical examination, previous relevant auxiliary examination results, etc. Evaluation scales: H-Y Staging Scale, UPDRS Scale, Breg Balance Scale, MMSE Intelligence Scale, MoCA Scale, SDS Depression Self-Rating Scale, SAS Anxiety Self-Rating Scale, PDSS Parkinson\&#39;s Disease Sleep Scale. Peripheral blood of patients and control groups were sampled to determine the levels of vitamin D, Treg and Th17. PD patients were divided into vitamin D deficiency group and vitamin D non-deficiency group according to the detection of vitamin D. Vitamin D deficiency group was randomly divided into intervention group and non-intervention group. The intervention group was supplemented with vitamin D, and the non-intervention group was not treated. The above scale and peripheral blood vitamin D, Treg and Th17 levels were evaluated after 3 months of follow-up and compared with the pre-intervention and non-intervention groups. Statistical analysis was carried out using SPSS26.0 and GraphPad Prism v.9.

Eligibility criteria: Inclusion Criteria:

* Meets the age requirement and is in good health.

Exclusion Criteria:

* Have related vitamin D metabolic diseases (kidney failure, severe liver damage, hereditary 1α hydroxylase deficiency, etc.).
* Have an immune system disorder.
* Have a history of disabling cerebrovascular disease.
* Have a grade 1 or 2 relative with PD.
* Have severe dementia, depression, or serious mental illness.
* Failure to sign the informed consent form.

Primary outcomes:
measure: Th17
timeFrame: Evaluation at the time of enrollment and intervention after three months.
measure: Treg
timeFrame: Evaluation at the time of enrollment and intervention after three months.
measure: Vitamin D
timeFrame: Evaluation at the time of enrollment and intervention after three months
Secondary outcomes:
measure: UPDRS
timeFrame: Evaluation at the time of enrollment and intervention after three months
measure: Berg balance scale
timeFrame: Evaluation at the time of enrollment and intervention after three months.
measure: MMSE
timeFrame: Evaluation at the time of enrollment and intervention after three months
measure: MoCA
timeFrame: Evaluation at the time of enrollment and intervention after three months
measure: SDS
timeFrame: Evaluation at the time of enrollment and intervention after three months
measure: SAS
timeFrame: Evaluation at the time of enrollment and intervention after three months.
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Suzhou Hospital of Anhui Medical University
state: Anhui
Study officials:
References: