UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000276 |
|---|---|
| Receipt number | R000000350 |
| Scientific Title | A controlled trial of zinc supplementation for decompensated liver cirrhosis |
| Date of disclosure of the study information | 2008/01/01 |
| Last modified on | 2011/05/03 21:30:36 |
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Basic information
Public title
A controlled trial of zinc supplementation for decompensated liver cirrhosis
Acronym
A controlled trial of zinc supplementation for decompensated LC
Scientific Title
A controlled trial of zinc supplementation for decompensated liver cirrhosis
Scientific Title:Acronym
A controlled trial of zinc supplementation for decompensated LC
Region
| Japan |
Condition
Condition
decompensated liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the effect of nitrogen metabolism and QOL of zinc supplementation for hyperammonemia in the patients with liver cirrhosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL(SF-36)
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
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
oral zinc supplementation + BCAA granule
Interventions/Control_2
only BCAA granule
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Decompensated liver cirrhosis more than 12 weeks during BCAA granule administration,and hyperammonemia(more than 50 micromol/l).
2.hepatic encephalopathy is present.
or the anamnestic patient (decompensated liver cirrhosis).
3.The prognosis obtained more than one year.
4.Age is within 20-80 years old
5.For patients with HCC the Milan criteria are applied (solitary tumor of less than 5 cm, or three or fewer lesions, none more than 3 cm without vascular invasion, or extrahepatic metastasis), and patients were to undergo potentially curative treatments with percutaneous ethanol injection therapy, combined with transcatheter arterial embolization, radiofrequency ablation therapy, or surgical resection.
6.We do not ask whether hospitalization or outpatient.
7.The patient is obtained an agreement by a document.
Key exclusion criteria
1.The patient with pregnancy or gravid possibility.
2.Advanced HCC, or other malignancy, its prognosis is less than 1 year.
3.Less than 2.5g/ml of serum albumin level
4.More than 3.0mg/dl of total bil.
5.Hepatic encephalopathy (possible anamnestic case) is higher than 3 degree.
6. The patients whom judged to be inadequate by clinical trial liability or clinical trial allotment doctor.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Takuma |
Organization
NHO IwakuniClinical Center
Division name
Department of Internal Medicine
Zip code
Address
Kuroiso-cho, Iwakuni, Yamaguchi 740-8510 Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
NHO IwakuniClinical Center
Division name
Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
takuma@enjoy.ne.jp
Sponsor or person
Institute
NHO IwakuniClinical Center
Institute
Department
Personal name
Funding Source
Organization
NHO IwakuniClinical Center
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 | 01 | Month | 01 | 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
| 2005 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 11 | Month | 03 | Day |
Last modified on
| 2011 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000350
