UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045176 |
|---|---|
| Receipt number | R000051613 |
| Scientific Title | Relationship between vitamin D concentration and sarcopenia in chronic liver diseas |
| Date of disclosure of the study information | 2021/08/18 |
| Last modified on | 2021/08/17 17:53:43 |
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Basic information
Public title
Relationship between vitamin D concentration and sarcopenia in chronic liver disease
Acronym
Relationship between vitamin D concentration and sarcopenia
Scientific Title
Relationship between vitamin D concentration and sarcopenia in chronic liver diseas
Scientific Title:Acronym
Relationship between vitamin D concentration and sarcopenia
Region
| Japan |
Condition
Condition
chronic hepatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the relationship between sarcopenia and vitamin D concentration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between Vitamin D concentration and presence / absence of sarcopenia, muscle mass, and muscle strength
Key secondary outcomes
Relationship between sarcopenia, muscle mass, strength and other endpoints
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic liver disease (including chronic hepatitis, cirrhosis, and decompensated cirrhosis)
20 years and over
Patients who usually undergo an abdominal CT examination (simple or contrast-enhanced) including lumbar spine L3 at the time of outpatient examination or hospitalization
Key exclusion criteria
No exclusion criteria
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | TOMOMI |
| Middle name | |
| Last name | OKUBO |
Organization
Nippon Medical School Chiba Hokuso Hospital
Division name
Gastroenterology
Zip code
2701613
Address
1715 Kamagari Inzai Chiba
TEL
0476991111
ma6-0154@nms.ac.jp
Public contact
Name of contact person
| 1st name | TOMOMI |
| Middle name | |
| Last name | OKUBO |
Organization
Nippon Medical School Chiba Hokuso Hospiital
Division name
Gastroenterology
Zip code
2701613
Address
1715 Kamagari Inzai Chiba
TEL
0476991111
Homepage URL
ma6-0154@nms.ac.jp
Sponsor or person
Institute
Nippon Medical Chiba Hokuso Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical Chiba Hokuso Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Chiba Hokouso Hospital
Address
1715 Kamagari Inzai Chiba
Tel
0476991111
araraki@nms.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 | 08 | Month | 18 | 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
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
CT will be used to measure muscle mass and diagnose sarcopenia. In addition, the muscle mass at the third lumbar vertebra level required for sarcopenia diagnosis from the abdominal CT image is analyzed using the software built into the computer for analysis. For the diagnosis of sarcopenia, the criteria for sarcopenia (1st edition) proposed by the Japanese Society of Hepatology are used.
Management information
Registered date
| 2021 | Year | 08 | Month | 17 | Day |
Last modified on
| 2021 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051613
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
