UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027717 |
|---|---|
| Receipt number | R000031752 |
| Scientific Title | The investigation about bone metabolism and sarcopenia among chronic hepatitis C patients and the impacts of DAAs combination therapy. |
| Date of disclosure of the study information | 2017/06/11 |
| Last modified on | 2023/06/16 18:15:42 |
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Basic information
Public title
The investigation about bone metabolism and sarcopenia among chronic hepatitis C patients and the impacts of DAAs combination therapy.
Acronym
The investigation about bone metabolism and sarcopenia among CHC patients and the impacts of DAAs.
Scientific Title
The investigation about bone metabolism and sarcopenia among chronic hepatitis C patients and the impacts of DAAs combination therapy.
Scientific Title:Acronym
The investigation about bone metabolism and sarcopenia among CHC patients and the impacts of DAAs.
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the actual situation of bone metabolism and sarcopenia among the CHC patients, and to clarify the impacts of DAAs combination therapy for CHC patients by analyzing the change of bone metabolism and sarcopenia before and after DAAs combination therapy.
Basic objectives2
Others
Basic objectives -Others
To clarify the changes of bone density, biochemical markers about bone metabolism, and muscular strength among the chronic hepatitis C patients who achieved SVR after DAAs combination therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of bone density, biochemical markers about bone metabolism, and muscular strength among the chronic hepatitis C patients who achieved SVR after DAAs combination therapy.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with chronic hepatitis C
Key exclusion criteria
1. Patient who already takes some medicine affecting bone density
2. Patient who is nursing or pregnant
3. Patient with uncontrolled heart failure
4. Patient with uncontrolled hypertension or diabetes
5. Patient with chronic renal failure
6. Patient with decompensated liver cirrhosis
7. Patient with other liver diseases, including autoimmune hepatitis, primary biliary cirrhosis and alcoholic hepatitis
8. Patient with positive result for hepatitis B surface antigen and antibody to human immunodeficiency virus type-1
9. Patient Judged by investigators not to be appropriate for inclusion in this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Atsukawa |
Organization
Nippon Medical School Chiba Hokusoh Hospital
Division name
Division of Gastroenterology
Zip code
2701196
Address
1715,Kamakari,Inzai,Chiba, Japan
TEL
0476-99-1111
atsukawa-nms@umin.ac.jp
Public contact
Name of contact person
| 1st name | Chisa |
| Middle name | |
| Last name | Kondo |
Organization
Nippon Medical School Chiba Hokusoh Hospital
Division name
Division of Gastroenterology
Zip code
2701196
Address
1715,Kamakari,Inzai,Chiba, Japan
TEL
0476-99-1111
Homepage URL
s8042@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Chiba Hokusoh Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Ehtics comitee of Nippon Medical School Chiba Hokusoh Hospital
Address
1715,Kamakari,Inzai,Chiba,
Tel
+81476991111
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
| 2017 | Year | 06 | Month | 11 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/31914479/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31914479/
Number of participants that the trial has enrolled
204
Results
The prevalence of sarcopenia in the cirrhotic patients was significantly higher than that in the noncirrhotic patients. Sarcopenia was diagnosed in 27.5% of the 160 patients with vitamin D deficiency, and 4.5% of the 44 patients without vitamin D deficiency. On multivariate analysis, advanced age, low bodymass index and low serum 25(OH)D3 level were significant independent factors associated with sarcopenia. Serum 25(OH)D3 was positively correlated with grip strength and skeletal muscle mass index.
Results date posted
| 2023 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study included a total of 204 patients with chronic liver disease,comprising 43.1% men and 56.9% women with a median age of 67 years(range 24-88 years).
The causes of liver disease were CHC (n = 85), CHB (n = 17), alcoholic liver disease (n = 25), non-alcoholic fatty liver disease (n = 36), primary biliary cholangitis
(n = 19), autoimmune hepatitis (n =13), and others/unknown etiology (n = 9). A total of 18 (8.8%) patients had undergone hepatocellular carcinoma treatment.
In the study cohort, 76 (37.3%) patients were diagnosed with cirrhosis, whereas the remaining 128 (62.7%) patients did not receive a diagnosis of cirrhosis.
The median serum 25(OH)D3 level was 14.3 ng/mL.
Participant flow
This study included 204 patients with chronic liver disease who visited Nippon Medical School Chiba Hokusoh Hospital in Chiba, Japan, between March 2017 and September 2018. The primary inclusion criteria were as follows; chronic hepatitis diagnosed by laboratory tests and imaging modalities, such as computed tomography and ultrasonography,(ii) patient age >20 years, (iii) no supplementation with calcium or vitamin D, (iv) acquisition of written informed consent for analyses of serum, and (v) absence of parathyroid dysfunction and liver failure.The exclusion criteria were as follows; (i) pregnancy, (ii) pacemaker use, and (iii) presence of uncontrollable ascites.
Adverse events
None
Outcome measures
The factors associated with sarcopenia, including serum vitamin D level, in patients with chronic liver disease.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study analyzed the data of consecutive patients with chronic hepatitis C from February, 2017.
Management information
Registered date
| 2017 | Year | 06 | Month | 11 | Day |
Last modified on
| 2023 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031752
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| Registered date | File name |
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