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临床试验/NCT06539260
NCT06539260已完成早期 1 期

Clinical Relationship Between Vitamin D-mediated Th17 and Treg Cells and Parkinson's Disease

Suzhou Municipal Hospital of Anhui Province1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Vitamin D

研究概览

简要总结

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'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's disease, ultimately providing new theoretical evidence for the research, prevention, and treatment of PD.

详细描述

FromJanuary 2023 to July 2024, 50 PD patients and 50 health control groups were collected. All subjects were from the Parkinson'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'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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meets the age requirement and is in good health.

排除标准

  • 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.

研究组 & 干预措施

VitD group

Experimental

The Parkinson's disease patients included in the study underwent analysis of peripheral blood vitamin D levels, among other assessments. Patients with low vitamin D levels (Vit D < 30 ng/ml) were randomly assigned in a 1:1 ratio to two groups: one receiving vitamin D3 and the other receiving a placebo (PL). The vitamin D group was supplemented with vitamin D for a period of 3 months.

干预措施: Vitamin D (Drug)

PL group

Placebo Comparator

The Parkinson's disease patients included in the study underwent analysis of peripheral blood vitamin D levels, among other assessments. Patients with low vitamin D levels (Vit D < 30 ng/ml) were randomly assigned in a 1:1 ratio to two groups: one receiving vitamin D3 and the other receiving a placebo (PL). The placebo group was supplemented with a placebo for a period of 3 months.

干预措施: Placebo (Drug)

结局指标

主要结局

Vitamin D

时间窗: Evaluation at the time of enrollment and intervention after three months

Detect the level of Vitamin D in peripheral blood.

Th17

时间窗: Evaluation at the time of enrollment and intervention after three months.

Detect the level of Th17 in peripheral blood.

Treg

时间窗: Evaluation at the time of enrollment and intervention after three months.

Detect the level of Treg in peripheral blood.

次要结局

  • UPDRS(Evaluation at the time of enrollment and intervention after three months)
  • MoCA(Evaluation at the time of enrollment and intervention after three months)
  • SAS(Evaluation at the time of enrollment and intervention after three months.)
  • Berg balance scale(Evaluation at the time of enrollment and intervention after three months.)
  • MMSE(Evaluation at the time of enrollment and intervention after three months)
  • SDS(Evaluation at the time of enrollment and intervention after three months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xibo Ma

learned scholar

Suzhou Municipal Hospital of Anhui Province

研究点 (1)

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