UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001534 |
|---|---|
| Receipt number | 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 19:51:32 |
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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
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
sakai429@hotmail.com
Sponsor or person
Institute
Hyogo College Medicine
Department of internal medicine
Division of Hepatobiliary and Pancreatc Disease
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001854
