NCT06539260

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Suzhou Municipal Hospital of Anhui Province · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

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\'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.

Detailed description

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.

Conditions

• Neurology
• Immunology

Interventions

Type	Name	Description
DRUG	Vitamin D	Take 400 units of vitamin D3, twice daily, for a duration of 3 months.
DRUG	Placebo	Take a placebo that is identical in appearance and weight to 400 units of vitamin D3, twice daily, for a duration of 3 months.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2024-08-06
• Last updated: 2024-08-26

Locations

1 site across 1 country: China