UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049866 |
|---|---|
| Receipt number | R000056800 |
| Scientific Title | The survey of effects of oral nutrition supplements on an intake compliance in acute phases |
| Date of disclosure of the study information | 2022/12/22 |
| Last modified on | 2023/03/30 14:06:05 |
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Basic information
Public title
The survey of effects of oral nutrition supplements on an intake compliance in acute phases
Acronym
ONS questionnaire survey
Scientific Title
The survey of effects of oral nutrition supplements on an intake compliance in acute phases
Scientific Title:Acronym
ONS questionnaire survey
Region
| Japan |
Condition
Condition
After surgery, after acute illness and COVID-19 infection
Classification by specialty
| Infectious disease | Gastrointestinal surgery | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of oral nutrition supplement ONS types on an intake compliance
Basic objectives2
Others
Basic objectives -Others
To investigate the satisfaction by oral nutrition supplement ONS types
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
compliance by the questionnaire
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Admitted to Hitachi General Hospital.
After surgery, after acute illness, and COVID-19 infection
Key exclusion criteria
nothing
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Takahashi |
Organization
Hitachi General Hospital
Division name
Emergency and Critical Care Medicine
Zip code
3170077
Address
2-1-1 Jonancho Hitachi Ibaraki Japan
TEL
0294231111
knakamura-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Nakamura |
Organization
Hitachi General Hospital
Division name
Emergency and Critical Care Medicine
Zip code
3170077
Address
2-1-1 Jonancho Hitachi Ibaraki Japan
TEL
0294231111
Homepage URL
knakamura-tky@umin.ac.jp
Sponsor or person
Institute
Hitachi General Hospital
Institute
Department
Personal name
Funding Source
Organization
Nestle Japan
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
Hitachi General Hospital
Address
Hitachi General Hospital
Tel
094231111
knakamura-tky@umin.ac.jp
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
| 2022 | Year | 12 | Month | 22 | 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
| 2022 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
questionnaire survey
Management information
Registered date
| 2022 | Year | 12 | Month | 22 | Day |
Last modified on
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056800
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/06/23 | (タハ)D案件（計画書）.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
