UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001534
Receipt No. R000001854
Scientific Title Controlled comparative study for nutritional improvement among branched chain amino acids(BCAA),general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices.
Date of disclosure of the study information 2008/11/30
Last modified on 2014/06/09

* 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 Controlled comparative study for nutritional improvement among branched chain amino acids(BCAA),general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices.
Acronym Controlled comparative study for nutritional improvement among BCAA,general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices.
Scientific Title Controlled comparative study for nutritional improvement among branched chain amino acids(BCAA),general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices.
Scientific Title:Acronym Controlled comparative study for nutritional improvement among BCAA,general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices.
Region
Japan

Condition
Condition esophageal varices
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the nutritional improvement among branched chain amino acids(BCAA),general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes 1.The rate of improvement in nutritional metabolism using indirect calorimetry
The starting date of study is defined as day0, and endscopic therapies are conducted on day0,day7 and day14. The rate of improvement in non-protein respiratory quotient(npRQ) using indirect calorimetry are evaluated every therapic day.
Key secondary outcomes 1.The rate of improvement by Subjective Global Assessment
The rate of improvements in subjective symptom and physical measurement are evaluated on day0,day7,day14,and day56.
2.The transition of serum protein
The transitional changes of serum albumin, pre-albumin, retinol-binding protein(RBP), branched chain amino acid & tyrosine ratio(BTR) are evaluated on day0,day7,day14,and day56.
3.The changes of glucose tolerance
Glucose tolerance in fasting blood sugar,immunoreactive insulin(IRI) are evaluated on day0,day7,day14,and day56


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients without BCAA before this study.
This group reseives no additional nutrient during whole period of this study.(GroupA)
Interventions/Control_2 Patients without BCAA before this study.
This group reseives two packs of a general liquid nutrient(Racol) per day in two divided breakfast and bedtime during first 14days.Thereafter,no additional nutrient is administered till the end of this study.(GroupB)
Interventions/Control_3 Patients without BCAA before this study.
This group reseives two packs of a BCAA-rich nutrient(AminolebanEN) per day in two divided breakfast and bedtime during first 14days,and one pack per day in one divided bedtime next 42days.(GroupC)
Interventions/Control_4 Patients with BCAA before this study.
This group reseives three packs of a BCAA(Livact) per day in two divided breakfast and bedtime during first 14days,and three pack per day in three divided breakfast lunch dinner next 42days.(GroupD)
Interventions/Control_5 Patients with BCAA before this study.
This group reseives two packs of a BCAA-rich nutrient(AminolebanEN) per day in two divided breakfast and bedtime during first 14days,and next 42days.(GroupE)
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.patients with esophageal varices who will receive endscopic therapy.
2.patients who understand the study contents and give informed consents by themselves.
Key exclusion criteria 1.patients who took regular administration of albumin products more than once a week for one month.
2.patients with severe disorder of glucose metabolism.
3.patients with severe renal failure.
4.patients with congenital disorder of amino-acid metabolism.
5.patients who are regarded in-eligible by the doctor who participates in this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name shuhei nishiguchi
Organization Hyogo College of Medicine
Division name Department of Internal Medicine Division of Hepatobiliary and Pancreatc Disease
Zip code
Address 1-1 Mukogawa-cho Nishinomiya
TEL 0798-45-6111
Email nishiguc@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name yshiyuki sakai
Organization Hyogo College of Medicine
Division name Department of Internal Medicine Division of Hepatobiliary and Pancreatc Disease
Zip code
Address 1-1 Mukogawa-cho Nishinomiya
TEL 0798-45-6111
Homepage URL
Email sakai429@hotmail.com

Sponsor
Institute Hyogo College Medicine
Department of internal medicine
Division of Hepatobiliary and Pancreatc Disease
Institute
Department

Funding Source
Organization Hyougo College of Medicine
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
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
2008 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results 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
2008 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
2013 Year 04 Month 01 Day
Date trial data considered complete
2013 Year 04 Month 01 Day
Date analysis concluded
2013 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 11 Month 30 Day
Last modified on
2014 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001854

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.