UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008723
Receipt number R000009269
Scientific Title The effect of carnitine supplementation for the liver cirrhosis patients with hyperammonemia -a preliminary randomized controlled study
Date of disclosure of the study information 2012/08/20
Last modified on 2012/08/20 10:02:09

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Basic information

Public title

The effect of carnitine supplementation for the liver cirrhosis patients with hyperammonemia -a preliminary randomized controlled study

Acronym

Carnitine supplementation for the liver cirrhosis

Scientific Title

The effect of carnitine supplementation for the liver cirrhosis patients with hyperammonemia -a preliminary randomized controlled study

Scientific Title:Acronym

Carnitine supplementation for the liver cirrhosis

Region

Japan


Condition

Condition

Cirrhosis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate improvement of hyperammonemia by supplementation of carnitine.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary endpoint is to evaluate the change of blood ammonia level.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Study drug was 600mg t.d.s. carnitine per day for 8weeks.

Interventions/Control_2

Study drug was 900mg t.d.s. carnitine per day for 8weeks.

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

Liver cirrhosis patients who complicated hyperammonemia, despite of taking dietary management more than 30 days.

Key exclusion criteria

1.Patients who are difficult to continue this study for treatment of hepatocarcinoma.
2.Patients complicated uncontrolled diabets.
3.Patients who diagnosed unfitness to attend the study by a physician.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichi Shiraishi

Organization

Tokai University School of Medicine

Division name

Department of Internal Medicine

Zip code


Address

143 Shimokasuya, Isehara city, Kanagawa 259-1193

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tokai University School of Medicine

Division name

Department of Internal Medicine

Zip code


Address

143 Shimokasuya, Isehara city, Kanagawa 259-1193

TEL

+81-463-93-1121

Homepage URL


Email



Sponsor or person

Institute

Tokai University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Tokai University School of Medicine

Organization

Division

Category of Funding Organization

Other

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

2012 Year 08 Month 20 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

Open public recruiting

Date of protocol fixation

2012 Year 05 Month 11 Day

Date of IRB


Anticipated trial start date

2012 Year 05 Month 01 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

2012 Year 08 Month 20 Day

Last modified on

2012 Year 08 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009269


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name