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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002402
Receipt No. R000002846
Scientific Title Study of effects of Nobelzin capsules (zinc acetate) on hyperammonemia in patients with liver cirrhosis; A randomized, double-blind, placebo-controlled study in patients with liver cirrhosis
Date of disclosure of the study information 2009/09/15
Last modified on 2014/09/18

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Basic information
Public title Study of effects of Nobelzin capsules (zinc acetate) on hyperammonemia in patients with liver cirrhosis; A randomized, double-blind, placebo-controlled study in patients with liver cirrhosis
Acronym Effects of Zinc supplementation on Hyperammonemia in patients with Liver Cirrhosis (EZ trial)
Scientific Title Study of effects of Nobelzin capsules (zinc acetate) on hyperammonemia in patients with liver cirrhosis; A randomized, double-blind, placebo-controlled study in patients with liver cirrhosis
Scientific Title:Acronym Effects of Zinc supplementation on Hyperammonemia in patients with Liver Cirrhosis (EZ trial)
Region
Japan

Condition
Condition Liver Cirrhosis
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects and safety of zinc acetate on hyperammonemia in patients with liver cirrhosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Serum levels of ammonia (0-week and 12-week)
Adverse effects(during trial, 0-12 week)
Key secondary outcomes Serum levels of BTR, psychometric testing, hepatic coma grade (0-week and 12-week)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patietns will receive 3 capsules of Nobelzin (zinc acetate, 1 capsule includes 50mg zinc) per day for 12 weeks
Interventions/Control_2 Patietns will receive 3 capsules of placebo per day for 12 weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Liver Cirrhosis
2.Hyperammonemia >= ULN (more than 2 times within the past 2 months)
3.Hepatic coma grade <= 2
4.Serum levels of zinc <= 65 microgram/dl
5.Ages 20 or older
6.Out-clinic patients
Key exclusion criteria 1.Hepatic coma grade >= 3
2.Fulminant hepatitis
3.Patients with malignant diseases who need to be treated during the period of this trial
4.Patients with cardiac, renal or pancreatic diseases who need admission for the therapy
5.Patients who are associated with heavy hematological disorders or cerebrovascular diseases
6.Known or suspected history of allergy to zinc
7.Inegible patients at a physician's discretion
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyuki Suzuki
Organization Iwate Medical University, School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address 19-1, Uchimaru, Morioka, Iwate, 020-8505, Japan
TEL 019-651-5111
Email ryuendo@iwate-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryujin Endo
Organization Iwate Medical University, School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address 19-1, Uchimaru, Morioka, Iwate, 020-8505, Japan
TEL 019-651-5111
Homepage URL
Email ryuendo@iwate-med.ac.jp

Sponsor
Institute Ministry of Health, Labour and Welfare
Institute
Department

Funding Source
Organization Research grant from the Japanese Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2009 Year 09 Month 15 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
This is the first randomized-controlled trial to show that zinc supplementation for 3 months seems effective and safe for treating hyperammonemia in liver cirrhosis. 
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
2009 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 07 Month 31 Day
Date trial data considered complete
2013 Year 08 Month 31 Day
Date analysis concluded
2013 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 29 Day
Last modified on
2014 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002846

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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