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Completed

NCT Number: NCT06539260

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

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.

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Key information

Conditions

Neurology Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Immunology Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Suzhou Hospital of Anhui Medical University

Suzhou, Anhui, 234000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D

Drug

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

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.

Primary outcomes

  1. Th17

    Time frame: Evaluation at the time of enrollment and intervention after three months.

    Detect the level of Th17 in peripheral blood.

  2. Treg

    Time frame: Evaluation at the time of enrollment and intervention after three months.

    Detect the level of Treg in peripheral blood.

  3. Vitamin D

    Time frame: Evaluation at the time of enrollment and intervention after three months

    Detect the level of Vitamin D in peripheral blood.

Secondary outcomes

  1. UPDRS

    Time frame: Evaluation at the time of enrollment and intervention after three months

    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.

  2. Berg balance scale

    Time frame: Evaluation at the time of enrollment and intervention after three months.

    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.

  3. MMSE

    Time frame: Evaluation at the time of enrollment and intervention after three months

    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.

  4. MoCA

    Time frame: Evaluation at the time of enrollment and intervention after three months

    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.

  5. SDS

    Time frame: Evaluation at the time of enrollment and intervention after three months

    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.

  6. SAS

    Time frame: Evaluation at the time of enrollment and intervention after three months.

    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.

Sponsors and collaborators

Lead sponsor

Suzhou Municipal Hospital of Anhui Province

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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