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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011183
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kanazawa Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013097

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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