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

NCT ID: NCT06539260

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-07-01

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'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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

VitD group

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.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

Take 400 units of vitamin D3, twice daily, for a duration of 3 months.

PL group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Take a placebo that is identical in appearance and weight to 400 units of vitamin D3, twice daily, for a duration of 3 months.

Interventions

Vitamin D

Take 400 units of vitamin D3, twice daily, for a duration of 3 months.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suzhou Municipal Hospital of Anhui Province

OTHER

Sponsor Role: lead

Responsible Party

Xibo Ma

learned scholar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Suzhou Hospital of Anhui Medical University

Suzhou, Anhui, China

Countries

China

References

Li D, Ma X, Zhang W, Zhong P, Li M, Liu S. Impact of vitamin D3 supplementation on motor functionality and the immune response in Parkinson's disease patients with vitamin D deficiency. Sci Rep. 2025 Jul 11;15(1):25154. doi: 10.1038/s41598-025-10821-5.

Reference Type: DERIVED

PMID: 40646117 (View on PubMed)

Other Identifiers

AHWJ2022b106

Identifier Type: OTHER

Identifier Source: secondary_id

SuzhouAnhuiPD

Identifier Type: -

Identifier Source: org_study_id