UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of 9-cis beta-carotene on retinal function of fundus albipunctatus
Title of the study (Brief title)	Effect of 9-cis beta-carotene on fundus albipunctatus
Region	Japan

Condition
Condition	Fundus albipunctatus
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine whether oral administration of 9-cis beta-carotene (Dunaliella) improves night blindness in funds albipunctatus.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Improvement of the amplitude of electroretinogram
Key secondary outcomes	Improvement of the visual acuity and visual field

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Oral administration of beta-carotene (Dunaliella)
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with funds albipunctatus, who were diagnosed by fundus photograph, electroretinogram, and genetic analysis (RDH5). 2) Patients with funds albipunctatus (age, 20 years or elder), who agreed to participate in this study.
Key exclusion criteria	1) Patients who have any other eye diseases. 2) Patients who had received any vitrectomy surgery. 3) Patients who used any steroid drugs within 3 months. 4) Patients who have allergies to beta-carotene.
Target sample size	10

Research contact person
Name of lead principal investigator	Mineo Kondo
Organization	Mie University School of Medicine
Division name	Ophthalmology
Address	2-174 Edobashi, Tsu 514-8507, Japan
TEL	059-231-5027
Email	mineo@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Mineo Kondo
Organization	Mie University School of Medicine
Division name	Ophthalmology
Address	2-174 Edobashi, Tsu 514-8507, Japan
TEL	059-231-5027
Homepage URL
Email	mineo@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University School of Medicine
Institute
Department

Funding Source
Organization	Mie University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

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	三重大学医学部附属病院（三重県）、名古屋大学医学部附属病院（愛知県）、慈恵医科大学附属病院（東京）

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 07 Day
Anticipated trial start date	2015 Year 05 Month 07 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	2018 Year 12 Month 31 Day
Date analysis concluded	2019 Year 12 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 05 Month 25 Day
Last modified on	2019 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020490