UMIN-CTR Clinical Trial

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
Email	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
Email	k.hayamizu@hamayaku.ac.jp

Sponsor
Institute	Yokohama University of Pharmacy
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038042