UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022902 |
|---|---|
| Receipt number | R000026391 |
| Scientific Title | Effects of switching from branched chain amino acids (BCAA) medication to BCAA-enriched nutrient in patients with liver cirrhosis |
| Date of disclosure of the study information | 2016/06/27 |
| Last modified on | 2018/09/03 19:39:15 |
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Basic information
Public title
Effects of switching from branched chain amino acids (BCAA) medication to BCAA-enriched nutrient in patients with liver cirrhosis
Acronym
Effects of switching from branched chain amino acids (BCAA) medication to BCAA-enriched nutrient in patients with liver cirrhosis
Scientific Title
Effects of switching from branched chain amino acids (BCAA) medication to BCAA-enriched nutrient in patients with liver cirrhosis
Scientific Title:Acronym
Effects of switching from branched chain amino acids (BCAA) medication to BCAA-enriched nutrient in patients with liver cirrhosis
Region
| Japan |
Condition
Condition
Cirrhotic patients
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of switching from branched chain amino acids (BCAA) medication to BCAA-enriched nutrient in patients with liver cirrhosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum albumin at 6 and 12 months after baseline
Key secondary outcomes
Transthyretin, The molar ratio of branched-chain amino acids(BCAA) to tyrosine (BTR) at 6 and 12 months after baseline
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switch to 2 packs of BCAA-enriched nutrient mixture in the patients with less than 3.5 g/dl of serum albumin levels despite treatment with 3 packs of BCAA medication.
Interventions/Control_2
Continue the treatment with 3 packs of BCAA medication.
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
1. decompensated cirrhosis
2. serum albumin levels were less than 3.5 g/dl despite treatment with 3 packs of BCAA medication
3. over 20 years-old
4. written informed consent
Key exclusion criteria
1. history of hypersensitivity to amino acid
2. congenital disorders of amino acid metabolism
3. hypoalbuminemia from non-hepatic disease
4. judged inadequate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Yoshioka |
Organization
Fujita Health University
Division name
Department of Liver, Biliary Tract and Pancreas Diseases
Zip code
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
TEL
0562-93-2324
kyoshiok@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Yoshioka |
Organization
Fujita Health University
Division name
Department of Liver, Biliary Tract and Pancreas Diseases
Zip code
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
TEL
0562-93-2324
Homepage URL
kyoshiok@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
Address
Tel
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
| 2016 | Year | 06 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 27 | Day |
Last modified on
| 2018 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026391
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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