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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024024
Receipt No. 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

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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
Email 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
Email tsutsumi@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027664

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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