UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043294 |
|---|---|
| Receipt number | R000049136 |
| Scientific Title | Study of blood carnitine levels in patients with Parkinson's disease |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2024/03/26 14:18:11 |
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Basic information
Public title
Study of blood carnitine levels in patients with Parkinson's disease
Acronym
Study of blood carnitine levels in patients with Parkinson's disease
Scientific Title
Study of blood carnitine levels in patients with Parkinson's disease
Scientific Title:Acronym
Study of blood carnitine levels in patients with Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Parkinson's disease is a disease that causes muscle weakness, and carnitine, which is mainly stored in muscle, may be reduced. To clarify the relationship between Parkinson's disease and blood carnitine concentration.
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between Parkinson's disease and blood carnitine concentration.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total blood carnitine concentration
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Must have a definitive diagnosis of Parkinson's disease or multiple system atrophy.
2) Patients over 20 years old (at the time of obtaining consent). Gender does not matter.
Key exclusion criteria
1) Patients who have difficulty understanding the instructions of the examiner such as blood sampling
2) Patients with a history of diseases that affect blood carnitine levels
3) Patinets taking drugs that affect blood carnitine levels
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Heisuke |
| Middle name | |
| Last name | Mizukami |
Organization
St.Marianna University School of Medicine
Division name
Neurology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa
TEL
044-977-8111
h2mizukami@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Heisuke |
| Middle name | |
| Last name | Mizukami |
Organization
St.Marianna University School of Medicine
Division name
Neurology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
h2mizukami@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St.Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St.Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae, Kawasaki, Kanagawa
Tel
044-977-8111
h2mizukami@marianna-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2021 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
The purpose of this study is to clarify the relationship between Parkinson's disease and blood carnitine concentration. In addition, we will clarify the relationship between body weight, BMI, muscle mass measurement by DXA (Dual Energy X-ray absorptiometry), various blood sampling items, and blood carnitine concentration.
The subjects are Parkinson's disease patients and multiple system atrophy patients. Collect the following items and clinical information and compare the two groups.
1) Patient clinical information, 2) Blood findings
The measurement shall be taken at the time of obtaining consent or within one month after obtaining consent.
Management information
Registered date
| 2021 | Year | 02 | Month | 10 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049136
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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