UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001893 |
|---|---|
| Receipt number | R000002284 |
| Scientific Title | Randomized controlled trial of the combination of exercise therapy and BCAA supplementation for chronic liver diseases |
| Date of disclosure of the study information | 2009/05/01 |
| Last modified on | 2009/04/16 18:49:48 |
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Basic information
Public title
Randomized controlled trial of the combination of exercise therapy and BCAA supplementation for chronic liver diseases
Acronym
Randomized controlled trial of the combination of exercise therapy and BCAA supplementation for chronic liver diseases (RCEBL)
Scientific Title
Randomized controlled trial of the combination of exercise therapy and BCAA supplementation for chronic liver diseases
Scientific Title:Acronym
Randomized controlled trial of the combination of exercise therapy and BCAA supplementation for chronic liver diseases (RCEBL)
Region
| Japan |
Condition
Condition
chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to claryfy the effect of combination of exercise therapy and BCAA supplementation to the symptoms, nutritional status and quality of life of chronic liver disease patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Nutritional status after 6 weeks from the registration
Key secondary outcomes
Symptoms, quality of life of patients and immunological competences after 6 weeks from the registration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Combination of 12g of daily branched-chain amino acid supplementation (Aminofeel)and controlled exercise therapy along with 6 weeks of nutritional support including late evening snack
Interventions/Control_2
12g of daily branched-chain amino acid supplementation (Aminofeel) along with 6 weeks of nutritional support including late evening snack
Interventions/Control_3
Controlled exercise therapy along with 6 weeks of nutritional support including late evening snack
Interventions/Control_4
6 weeks of nutritional support including late evening snack
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with muscle atrophy
2.Serum albumin concentration =<4g/dl
3.Serum branched-chain amino acid/tyrosine molar ratio (BTR) =< 4.41
4.Patients who give documentary informed consent voluntarily
Key exclusion criteria
1.Patients with poor oral intake
2. Pasthistory of allergic reaction to the ingredients of Aminofeel
3.Patients with risky varices for upper GI bleeding
4. Patients of diabetes with poor control of the concentration of blood sugar
5. Patients of hypertention with poor control of blood pressure
6. Patients with history of severe cardiovascular diseases
7.Patients with clinical manifestation of hepatic encephalopathy
8.Patients inappropriate for participating to this study decided by the attending physicians.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Fukushima |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo Aoba Sendai Miyagi, Japan
TEL
022-717-7171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Fukushima |
Organization
Tohoku University Hospital
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo Aoba Sendai Miyagi, Japan
TEL
022-717-7171
Homepage URL
kofukushima-gi@umin.net
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Terumo Co.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2009 | Year | 05 | Month | 01 | 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
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 16 | Day |
Last modified on
| 2009 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002284
| 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 |
