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NeurologyEarly Phase 1NCT06539260

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

A Early Phase 1 study testing Vitamin D in people with Neurology and Immunology, run by Suzhou Municipal Hospital of Anhui Province at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Neurology, Immunology
What is being tested?
Vitamin D
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteChina
Study dates
1 Jan 2023to 1 Jul 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Meets the age requirement and is in good health.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Suzhou Hospital of Anhui Medical University

    Suzhou, Anhui, 234000

Other trials in China

About this study

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.

Read the 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.

Being tested
Vitamin D, Placebo
Keywords
Parkinson's disease, Vitamin D, Treg, Th17
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin DDrug

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

  • PlaceboDrug

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

Study groups in NCT06539260
Study groupRoleWhat they receive
VitD groupExperimentalThe 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.
Receives: Drug: Vitamin D
PL groupPlacebo comparatorThe 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Th17

    Detect the level of Th17 in peripheral blood.

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

  2. Treg

    Detect the level of Treg in peripheral blood.

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

  3. Vitamin D

    Detect the level of Vitamin D in peripheral blood.

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

Secondary outcomes (6)

  1. UPDRS

    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.

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

  2. Berg balance scale

    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.

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

  3. MMSE

    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.

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

  4. MoCA

    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.

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

  5. SDS

    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.

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

  6. SAS

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2024
  2. Study start1 Jan 2023
  3. Primary completion1 Jul 2024
  4. Study completion1 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06539260
Sponsor's protocol ID
SuzhouAnhuiPD
Other IDs
AHWJ2022b106
Status last verified
Aug 2024
First submitted
1 Aug 2024
Last updated
26 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40646117

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Vitamin D in people with Neurology and Immunology, run by Suzhou Municipal Hospital of Anhui Province at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Th17 (time frame: Evaluation at the time of enrollment and intervention after three months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06539260, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.

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