UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of effects of blackcurrant extract on suppression of myopia progression
Acronym	Investigation of effects of blackcurrant extract on suppression of myopia progression
Scientific Title	Investigation of effects of blackcurrant extract on suppression of myopia progression
Scientific Title:Acronym	Investigation of effects of blackcurrant extract on suppression of myopia progression
Region	Japan

Condition
Condition	Japanese healthy children in the ages greater than or equal 9, and less than 12
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of effects of continuous intake of blackcurrant extract for one year on suppression of myopia progression
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Eye axial length
Key secondary outcomes	Naked visual acuity, corrected visual acuity, objective refractive index (other-angle refractive index), intraocular pressure, contrast visual acuity, and questionnaire.

Base
Study type	Observational

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	9 years-old <=
Age-upper limit	12 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Healthy Japanese children in the ages greater than or equals to 8 and less than 12.(Gender ratio is intended to be 50/50) (2) A person who understood and agreed with the purpose of the clinical trial. The agreement document from the subject or its proxy is required based on the above understanding prior the clinical trial. (3) Persons who are able to comply with the requirements of the study, receive the medical examination prescribed in the protocol, and report symptoms and other information.
Key exclusion criteria	(1)Persons who are allergic to the test food (2)Any other person who is judged by the doctor responsible for the trial as in appropriate to participate in the study.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Osamu Middle name Last name Katsumi
Organization	Kashiwa Kibou Ophthalmology
Division name	director
Zip code	277-0922
Address	1-6-1-2F, Oshimada, Kashiwa City, Chiba
TEL	04-7157-0818
Email	o.katsumi729@i.softbank.jp

Public contact
Name of contact person	1st name Mamiko Middle name Last name Kohno
Organization	Morishita Jintan Co., Ltd.
Division name	Health Care Product Department
Zip code	101-0043
Address	10-2-6F, Kanda Tomiyama-cho, Chiyoda-ku, Tokyo
TEL	03-6206-8138
Homepage URL
Email	m_kohno@jintan.co.jp

Sponsor
Institute	Morishita Jintan Co., Ltd.
Institute
Department

Funding Source
Organization	Morishita Jintan Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Social medical corporation sokuinkai kouyou Clinic Clinical Trial Review Committee
Address	3-9 Hiroha-machi, Kitahiroshima City, Hokkaido
Tel	011-372-3900
Email	k-ohno@cli-creative.com

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	かしわ希望眼科（千葉県）

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 21 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	Open public recruiting
Date of protocol fixation	2020 Year 07 Month 17 Day
Date of IRB	2020 Year 07 Month 31 Day
Anticipated trial start date	2021 Year 09 Month 29 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	On or after November 21, 2020, subject recruitments will be conducted at the facility.

Management information
Registered date	2020 Year 11 Month 19 Day
Last modified on	2021 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048516