UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026278 |
|---|---|
| Receipt number | R000030177 |
| Scientific Title | Identification of nutritional markers which are not affected by inflammation |
| Date of disclosure of the study information | 2017/02/24 |
| Last modified on | 2018/02/28 10:25:12 |
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Basic information
Public title
Identification of nutritional markers which are not affected by inflammation
Acronym
Nutritional markers unsusceptible to inflammation
Scientific Title
Identification of nutritional markers which are not affected by inflammation
Scientific Title:Acronym
Nutritional markers unsusceptible to inflammation
Region
| Japan |
Condition
Condition
malnutrition
Classification by specialty
| Medicine in general | Surgery in general | Laboratory medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify nutritional markers which are not affected by inflammation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Relationship between changes of nutritional markers and inflammation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
The inpatients who were referred to Nutrition Support Team for malnutrition at Juntendo University Hospital
Key exclusion criteria
BMI >22
Anorexia nervosa
Cholestatic liver disease
End stage renal disease
Uncontrolled diabetes mellitus(HbA1c >10%)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Miida |
Organization
Juntendo University, Graduate School of Medicine
Division name
Department of Clinical Laboratory Medicine
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421
TEL
03-5802-1104
tmiida@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Hirayama |
Organization
Juntendo University, Graduate School of Medicine
Division name
Department of Clinical Laboratory Medicine
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421
TEL
03-5802-1104
Homepage URL
sthiraya@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Niigata University Medical and Dental Hospital
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
順天堂大学医学部附属順天堂医院（東京都）/Juntendo University Hospital (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 24 | 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
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | 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
Observation data includes patients' background, BMI, biomarkers of inflammation and nutritional markers.
Management information
Registered date
| 2017 | Year | 02 | Month | 23 | Day |
Last modified on
| 2018 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030177
