UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of switching from branched chain amino acids (BCAA) medication to BCAA-enriched nutrient in patients with liver cirrhosis
Title of the study (Brief title)	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	Kentaro Yoshioka
Organization	Fujita Health University
Division name	Department of Liver, Biliary Tract and Pancreas Diseases
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
TEL	0562-93-2324
Email	kyoshiok@fujita-hu.ac.jp

Public contact
Name of contact person	Kentaro Yoshioka
Organization	Fujita Health University
Division name	Department of Liver, Biliary Tract and Pancreas Diseases
Address	1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan
TEL	0562-93-2324
Homepage URL
Email	kyoshiok@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026391