UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024024 |
|---|---|
| Receipt number | R000027664 |
| Scientific Title | Efficacy and safety of oral rehydration therapy |
| Date of disclosure of the study information | 2016/09/15 |
| Last modified on | 2018/07/30 20:58:41 |
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Basic information
Public title
Efficacy and safety of oral rehydration therapy
Acronym
Efficacy and safety of oral rehydration therapy
Scientific Title
Efficacy and safety of oral rehydration therapy
Scientific Title:Acronym
Efficacy and safety of oral rehydration therapy
Region
| Japan |
Condition
Condition
adult volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of jelly as oral rehydration therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
free fatty acid
Key secondary outcomes
ketone body
3-methylhistidine
blood glucose level
blood insulin
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
an intake of jelly
Interventions/Control_2
non intake of jelly
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy adult
Key exclusion criteria
subject who has a complication and BMI(body mass index) is out of range.Smoking
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Tsutsumi |
Organization
Tokushima University
Division name
Anesthesiology
Zip code
Address
3-18-15 Kuramoto,Tokushima, 770-8503,JAPAN
TEL
+81-88-633-7181
tsutsumi@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Tsutsumi |
Organization
Tokushima University
Division name
Anesthesiology
Zip code
Address
3-18-15 Kuramoto,Tokushima, 770-8503,JAPAN
TEL
+81-88-633-7181
Homepage URL
tsutsumi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
department cost
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
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
| 2016 | Year | 09 | Month | 15 | 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
| 2017 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 05 | 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
| 2016 | Year | 09 | Month | 12 | Day |
Last modified on
| 2018 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027664
