UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001893
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email kofukushima-gi@umin.net

Sponsor
Institute Tohoku University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002284

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.