Clinical Relationship Between Vitamin D-mediated Th17 and Treg Cells and Parkinson's Disease
NCT Number: NCT06539260
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Neurology|Immunology
Interventions: DRUG: Vitamin D|DRUG: Placebo
Sponsor: Suzhou Municipal Hospital of Anhui Province
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-01-01
Completion Date: 2024-07-01
Locations: Suzhou Hospital of Anhui Medical University, Suzhou, Anhui, 234000, China

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.

Primary Outcome Measures: Th17, Detect the level of Th17 in peripheral blood., Evaluation at the time of enrollment and intervention after three months.|Treg, Detect the level of Treg in peripheral blood., Evaluation at the time of enrollment and intervention after three months.|Vitamin D, Detect the level of Vitamin D in peripheral blood., Evaluation at the time of enrollment and intervention after three months
Secondary Outcome Measures: UPDRS, Each item in the UPDRS (Unified Parkinson's Disease Rating Scale) is scored on a scale of 0 to 4, with 0 indicating normal and 4 indicating the most severe symptoms. The UPDRS can be divided into four subscales: the first subscale is used to assess the degree of mental activity, behavior, and emotional disorders in Parkinson's disease patients; the second subscale evaluates the patients' ability to perform activities of daily living; the third subscale, known as UPDRS-III, is the focus of the UPDRS scoring and assesses the motor function of PD patients, using 18 sub-items and a total of 132 points to describe the main motor symptoms of Parkinson's disease; the fourth subscale is used to evaluate treatment-related complications that occur during the course of PD treatment., Evaluation at the time of enrollment and intervention after three months|Berg balance scale, This scale consists of 14 items, each scored from 0 to 4. The sum of these items gives a total score ranging from 0 to 56, with higher scores indicating better balance., Evaluation at the time of enrollment and intervention after three months.|MMSE, This scale consists of 11 items, covering inquiries about orientation such as time and place, as well as assessments of memory, calculation ability, attention, recall ability, language skills, and visuospatial abilities. The language test further includes sub-tests for repetition ability, naming ability, command comprehension, reading ability, and writing ability. The total score for the MMSE is 30, and the entire test takes about 8-10 minutes to complete. A higher score indicates better cognitive function., Evaluation at the time of enrollment and intervention after three months|MoCA, It is an assessment tool used for rapid screening of cognitive dysfunction. It covers eight cognitive domains: visuospatial skills, executive function, memory, language, attention and concentration, calculation, abstract thinking, and orientation. The total score is 30, with a score of ≥26 considered normal., Evaluation at the time of enrollment and intervention after three months|SDS, This scale is an effective clinical tool for measuring subjective feelings of depression. It is a self-rating scale consisting of 20 items, each rated on a 4-point scale., Evaluation at the time of enrollment and intervention after three months|SAS, This scale is a self-rating scale consisting of 20 items, each rated on a 4-point scale, used to assess the subjective feelings of patients with anxiety., Evaluation at the time of enrollment and intervention after three months.