UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033371 |
|---|---|
| Receipt number | R000038042 |
| Scientific Title | Safety assessment of oral intake of L-Ornithine: Systematic review |
| Date of disclosure of the study information | 2019/04/30 |
| Last modified on | 2021/11/21 11:53:40 |
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Basic information
Public title
Safety assessment of oral intake of L-Ornithine: Systematic review
Acronym
Safety assessment of oral intake of L-Ornithine
Scientific Title
Safety assessment of oral intake of L-Ornithine: Systematic review
Scientific Title:Acronym
Safety assessment of oral intake of L-Ornithine
Region
| Japan |
Condition
Condition
Human who has received L-Ornithine by oral
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the tolerability of orally ingesting of L-ornithine.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All of adverse events
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
All studies which are intervention of L-Orn oral intake in human.
Key exclusion criteria
We exclude studies that is not oral intake of L-Orn or not clinical study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kohsuke |
| Middle name | |
| Last name | Hayamizu |
Organization
Yokohama University of Pharmacy
Division name
Laboratory of Food Chemistry
Zip code
245-0066
Address
601 Matano-cho, Totsuka-ku, Yokohama, Kanagawa, JAPAN
TEL
045-859-1300
k.hayamizu@hamayaku.ac.jp
Public contact
Name of contact person
| 1st name | Kohsuke |
| Middle name | |
| Last name | Hayamizu |
Organization
Yokohama University of Pharmacy
Division name
Laboratory of Food Chemistry
Zip code
244-0066
Address
601 Matano-cho, Totsuka-ku, Yokohama, Kanagawa, JAPAN
TEL
045-859-1300
Homepage URL
k.hayamizu@hamayaku.ac.jp
Sponsor or person
Institute
Yokohama University of Pharmacy
Institute
Department
Personal name
Funding Source
Organization
International Council on Amino Acid Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
meta-analysis
Address
meta-analysis
Tel
045-859-1300
k.hayamizu@hayamizu.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
| 2019 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
It was decided to suspend the project temporarily in order to improve the accuracy of the final results due to the information on the ongoing test regarding L-Orn.
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
Main results already published
Date of protocol fixation
| 2018 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Finished web based database search.
Under performing statistical analysis.
Interim analysis report finished
Management information
Registered date
| 2018 | Year | 07 | Month | 12 | Day |
Last modified on
| 2021 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038042
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
