UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002888 |
|---|---|
| Receipt number | R000003511 |
| Scientific Title | Efficacy of BCAA food additional intake added to dosage of medicine made of BCAA |
| Date of disclosure of the study information | 2009/12/14 |
| Last modified on | 2020/03/31 17:37:42 |
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Basic information
Public title
Efficacy of BCAA food additional intake added to dosage of medicine made of BCAA
Acronym
Efficacy of BCAA food addition intake in BCAA replenishment treatment
Scientific Title
Efficacy of BCAA food additional intake added to dosage of medicine made of BCAA
Scientific Title:Acronym
Efficacy of BCAA food addition intake in BCAA replenishment treatment
Region
| Japan |
Condition
Condition
decompensated cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effectiveness of the BCAA food addition intake in the BCAA substitution therapy to serum BTR and serum albumin is examined
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Serum BTR (branched chain amino acids / tyrosine molar ratio) and serum albumin revel after 12 weeks from the beginning of the dairy branched-chain amino acid supplementation intake
Key secondary outcomes
Quality of Life(SF-36) and Urinary 8-OHdG(8-Hydroxydeoxyguanosine) excretion after 12 weeks from the beginning of the dairy branched-chain amino acid supplementation intake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Medicine made of BCAA granules (4.0g) is taken 12 weeks continuously three times a day.
In addition, the BCAA supplementation (3.2g) is taken as late evening snack every day.
Interventions/Control_2
Medicine made of BCAA granules (4.0g) is taken 12 weeks continuously three times a day.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Decompensated cirrhosis
2. The dietary intake is possible.
3. Hypoalbuminemia
4. Patients who give documentary informed consent voluntarily
5. Patient who fills all of the above-mentioned 1-4
Key exclusion criteria
1. Patient who doesn't belong to application object of LIVACT
2. Patient who has the past of hepatic encephalopathy
3. Patient who has allergy in element of AMINOFEEL
4. The dietary intake is not enough in anorexia etc. , and the serum albumin is patients who decreased 0.1mg/dL or more in the past two months.
5. Patient who has infectious disease that becomes problem in clinical
6. Patient with serious glucose intolerance, respiratory failure and renal failure
7. Patient inappropriate for participating to this study decided by the attending physicians
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shuhei |
| Middle name | |
| Last name | Nishiguchi |
Organization
Hyogo College of Medicine
Division name
Division of Hepatobiliary and Pancreatic Diseases
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo, JAPAN
TEL
0798-45-6472
nishiguc@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Saito |
Organization
Hyogo College of Medicine
Division name
Division of Hepatobiliary and Pancreatic Diseases
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo, JAPAN
TEL
0798-45-6472
Homepage URL
he-jishu@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo College of Medicine
Address
Mukogawa-cho 1-1, Mishinomiya, Hyogo
Tel
0798-45-6154
shomu@hyo-med.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
| 2009 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000003511
Publication of results
Unpublished
Result
URL related to results and publications
No publication
Number of participants that the trial has enrolled
0
Results
No entry
Results date posted
| 2020 | Year | 03 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No entry
Participant flow
No entry
Adverse events
No entry
Outcome measures
No entry
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 14 | Day |
Last modified on
| 2020 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003511
| 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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