UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001376 |
|---|---|
| Receipt number | 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 08:42:38 |
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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
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
Sponsor or person
Institute
Shuwa General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001657
