UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001376
Receipt No. R000001657
Scientific Title A clinical study on micronutrients in the patients of gastrointestinal diseases receiving parenteral nutrition
Date of disclosure of the study information 2008/09/16
Last modified on 2009/10/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A clinical study on micronutrients in the patients of gastrointestinal diseases receiving parenteral nutrition
Acronym A clinical study on micronutrients in the patients of gastrointestinal diseases receiving parenteral nutrition
Scientific Title A clinical study on micronutrients in the patients of gastrointestinal diseases receiving parenteral nutrition
Scientific Title:Acronym A clinical study on micronutrients in the patients of gastrointestinal diseases receiving parenteral nutrition
Region
Japan

Condition
Condition In-patients of gastrointestinal diseases requiring parenteral nutrition
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the micronutrients in the patients of gastrointestinal diseases receiving parenteral nutrition
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Blood concentration/Urinary excretion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Study duration: 5 days
Frequency of micronutrient administration: none
Interventions/Control_2 Study duration: 5 days
Frequency of micronutrient administration: every day
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) Patients providing written informed consent
(2) Patients not youger than 20 years old (at the time of informed consent)
Key exclusion criteria (1) Patients with an abnormal electrolyte metabolism
(2) Patients with a congestive heart failure
(3) Patients with a serious liver failure (hepatic coma or possible hepatic coma)
(4) Patients with a serious kidney failure or azotemia
(5) Patients with an abnormal amino acid metabolism
(6) Patients with a severe acidosis
(7) Patients with a decreased urine volume due to the obstructive uropathy
(8) Patients with with a disease histry of hypersensitivity to the ingredients of intravenous solution
(9) Others who are deemed unsuitable for inclusion in the study for any other reason based on the assessment by the investigators
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Narihide Goseki
Organization Shuwa General Hospital
Division name Department of surgery
Zip code
Address 1200 Yaharashin-den, Kasukabe, Saitama
TEL 048-737-2121
Email

Public contact
Name of contact person
1st name
Middle name
Last name Narihide Goseki
Organization Shuwa General Hospital
Division name Department of surgery
Zip code
Address 1200 Yaharashin-den, Kasukabe, Saitama
TEL 048-737-2121
Homepage URL
Email

Sponsor
Institute Shuwa General Hospital
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization Profit organization
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
2008 Year 09 Month 16 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
2008 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2009 Year 07 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
2008 Year 09 Month 16 Day
Last modified on
2009 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001657

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.