UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051833 |
|---|---|
| Receipt number | R000059151 |
| Scientific Title | Retrospective Epidemiological Study of Carnitine Deficiency |
| Date of disclosure of the study information | 2023/08/05 |
| Last modified on | 2025/02/05 21:23:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Retrospective Epidemiological Study of Carnitine Deficiency
Acronym
Retrospective Epidemiological Study of Carnitine Deficiency
Scientific Title
Retrospective Epidemiological Study of Carnitine Deficiency
Scientific Title:Acronym
Retrospective Epidemiological Study of Carnitine Deficiency
Region
| Japan |
Condition
Condition
Carnitine Deficiency
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Epidemiological Features of Carnitine Deficiency
Basic objectives2
Others
Basic objectives -Others
Risk factors for carnitine deficiency and their epidemiological characteristics
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
prevalence
Key secondary outcomes
morbidity, risk factors for carnitine deficiency and their relative risk, attributable risk, odds ratio and so on.
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
Retrospective analysis of data obtained from an earlier clinical trial that measured carnitine.
Key exclusion criteria
Retrospective analysis of data obtained from an earlier clinical trial that measured carnitine
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ueno |
Organization
Guraduate School of Medical and Dental Sciences, Kagoshima University
Division name
Department of Rehabilitation and PhysicalMedicine
Zip code
890-8520
Address
Sakuragaoka 8-35-1, Kagoshima-City, Kagoshima, Japan
TEL
0992755339
k2764076@kadai.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ueno |
Organization
Social Medical Corporation Kohshinkai Kohshinkai Ogura Hospital
Division name
medical office
Zip code
893-0023
Address
27-22, Kasanohara-cho, Kanoya City, Kagoshima Prefecture, Japan
TEL
0994-44-7171
Homepage URL
k2764076@kadai.jp
Sponsor or person
Institute
Social Medical Corporation Kohshinkai Kohshinkai Ogura Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding
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
Social Medical Corporation Kohshinkai Kohshinkai Ogura Hospital
Address
27-22, Kasanohara-cho, Kanoya City, Kagoshima Prefecture, Japan
Tel
0994-44-7171
k2764076@kadai.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
| 2023 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000059151
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000059151
Number of participants that the trial has enrolled
150
Results
unpublished
Results date posted
| 2025 | Year | 02 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Hospitalized patients in a rehabilitation ward who underwent one blood tests during the observation period.
Participant flow
Inclusion criterion was that a patient be hospitalized in the rehabilitation ward for at least one day during the observation period.
Exclusion criteria were: (1) patients who refused use of their data in this study; (2) patients who had been hospitalized for over 60 days, including acute hospitalization days at their first carnitine measurement; (3) patients who experienced a new stroke or fracture during their present hospitalization; and (4) patients who had received L-carnitine prior to carnitine measurement.
Adverse events
No adverse events due to observational study.
Outcome measures
The primary outcomes were the proportions of patients with carnitine deficiency, high risk of carnitine deficiency, and carnitine insufficiency at the time of the first measurement. The secondary outcome was FIM motor score on discharge.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an exploratory, retrospective, observational study of the epidemiology of carnitine deficiency using existing blood test data. Epidemiological indicators such as prevalence of carnitine deficiency, other risk factors and their contributing risks will be the endpoints.
Management information
Registered date
| 2023 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059151
