UMIN-CTR Clinical Trial

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
Email	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
Email	ma6-0154@nms.ac.jp

Sponsor
Institute	Nippon Medical Chiba Hokuso Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051613