UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011183 |
|---|---|
| Receipt number | R000013097 |
| Scientific Title | Analysis of the effect of oral nutritional supplement or branched chain amino acid (BCAA) on liver cirrhotic patients with less than 3.5 g/dl of serum albumin level. |
| Date of disclosure of the study information | 2013/07/13 |
| Last modified on | 2015/08/03 09:54:32 |
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Basic information
Public title
Analysis of the effect of oral nutritional supplement or branched chain amino acid (BCAA) on liver cirrhotic patients with less than 3.5 g/dl of serum albumin level.
Acronym
Effect of oral nutritional supplement or BCAA on liver cirrhotic patients with less than 3.5 g/dl of serum albumin level.
Scientific Title
Analysis of the effect of oral nutritional supplement or branched chain amino acid (BCAA) on liver cirrhotic patients with less than 3.5 g/dl of serum albumin level.
Scientific Title:Acronym
Effect of oral nutritional supplement or BCAA on liver cirrhotic patients with less than 3.5 g/dl of serum albumin level.
Region
| Japan |
Condition
Condition
Liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, the effect of oral nutritional supplement or BCAA on serum albumin level, QOL, subjective and objective symptoms in liver cirrhotic patients with less than 3.5 g/dl of serum albumin level will be analyzed. Effect of nutritional supervision including late evening snacks (LES) provided by a dietician to control total caloric intake will be also analyzed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum albumin level
Usefulness of nutritional supervision including LES
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
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
Aminoleban EN powder mix
Interventions/Control_2
LIVACT Granules
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Cirrhotic patients with less than 3.5 g/dl of serum albumin level.
2.Cirrhotic patients diagnosed by physical, histological and/or ultrasound finding.
3.Patients who will be able to obtain written informed consent.
4.Patients who will be able to take drugs more than 3 months.
Key exclusion criteria
1.Patients who are taking branched chain amino acid or oral nutritional supplement for liver failure.
2.Patients treated with albumin preparation.
3.Patients with refractory ascites.
4.Patients with history of hypersensitive against drugs.
5.Patients with liver cancer.
6.Patient with serious complications such as renal failure.
7.Patients who are heavy drinker more than 5 years.
8.Patient with refractory diabetes mellitus.
9.Patients who are pregnant or breastfeeding.
10.Patients whom cannot be obtained a written informed consent.
11.Patients judged to be inappropriate for the study by the investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikihiro Tsutsumi |
Organization
Kanazawa Medical University
Division name
Hepatology
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-2211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikihiro Tsutsumi |
Organization
Kanazawa Medical University
Division name
Hepatology
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-2211
Homepage URL
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
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
| 2013 | Year | 07 | Month | 13 | 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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 12 | Day |
Last modified on
| 2015 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013097
