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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028914
Receipt No. R000033087
Scientific Title Safety assessment of oral intake of L-lysine.: Systematic review
Date of disclosure of the study information 2018/03/31
Last modified on 2019/01/10

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Basic information
Public title Safety assessment of oral intake of L-lysine.: Systematic review
Acronym Safety assessment of L-lysine
Scientific Title Safety assessment of oral intake of L-lysine.: Systematic review
Scientific Title:Acronym Safety assessment of L-lysine
Region
Japan

Condition
Condition Human who has received L-lysine 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-lysine.
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-lysine oral intake in human.
Key exclusion criteria We exclude studies that is not oral intake of L-lysine or not clinical study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohsuke Hayamizu
Organization Yokohama University of Pharmacy
Division name Laboratory of Food Chemistry
Zip code
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
Middle name
Last name Kohsuke Hayamizu
Organization Yokohama University of Pharmacy
Division name Laboratory of Food Chemistry
Zip code
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
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
2018 Year 03 Month 31 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
Temporary no observed adverse effect level (NOAEL) was determined 6000 mg / man / day.
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 05 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information in press

Management information
Registered date
2017 Year 08 Month 30 Day
Last modified on
2019 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033087

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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