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

NCT06539260 | Completed Early Phase 1

• 2 other identifiers: SuzhouAnhuiPDAHWJ2022b106
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurology; Immunology

Keywords

Parkinson's disease; Vitamin D; Treg; Th17

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• UPDRS

  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

• MoCA

  Evaluation at the time of enrollment and intervention after three months

• SDS

  Evaluation at the time of enrollment and intervention after three months

Study Arms (2)

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.

Drug: Vitamin D

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.

Drug: Placebo

Interventions

Vitamin D DRUG

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

VitD group

Placebo 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.

PL group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets the age requirement and is in good health.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Municipal Hospital of Anhui Province: lead

Study Sites (1)

Suzhou Hospital of Anhui Medical University

Suzhou, Anhui, 234000, China

Location

Related Publications (1)

• 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.

  PMID: 40646117 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: learned scholar

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: January 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)