UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030106
Receipt number R000034375
Scientific Title Safety assessment of oral intake of inositol:Systematic review
Date of disclosure of the study information 2018/03/31
Last modified on 2022/11/28 16:23:38

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Basic information

Public title

Safety assessment of oral intake of inositol:Systematic review

Acronym

Safety assessment of inositol

Scientific Title

Safety assessment of oral intake of inositol:Systematic review

Scientific Title:Acronym

Safety assessment of inositol

Region

Japan


Condition

Condition

Human who has received insitol by oral.

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of the tolerability of oral ingesting of inositol.

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 intervension(RCT) of inositol oral intake in human.

Key exclusion criteria

Exclude studies which are not oral intake of inositol or not clinical studies.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Makoto
Middle name
Last name Nakano

Organization

Yokohama University of Pharmacy

Division name

Laboratory of Food Chemistry

Zip code

2450066

Address

601 Matano-cho, Totsuka-ku, Yokohama, Kanagawa, JAPAN

TEL

045-859-1300

Email

m.nakano@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

245-0066

Address

601 Matano-cho, Totsuka-ku, Yokohama, Kanagawa, JAPAN

TEL

045-859-1300

Homepage URL


Email

k.hayamizu@hamayaku.ac.jp


Sponsor or person

Institute

Yokohama University of Pharmacy

Institute

Department

Personal name



Funding Source

Organization

Yokohama University of Pharmacy

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Not applicable due to systematic review

Address

Not applicable due to systematic review

Tel

0458591300

Email

m.nakano@hamayaku.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

2018 Year 03 Month 31 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

Preinitiation

Date of protocol fixation

2017 Year 09 Month 10 Day

Date of IRB


Anticipated trial start date

2017 Year 11 Month 24 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry

2018 Year 12 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 05 Month 31 Day


Other

Other related information

On going electrical search


Management information

Registered date

2017 Year 11 Month 24 Day

Last modified on

2022 Year 11 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034375


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name