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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017676
Receipt No. R000020490
Scientific Title Effect of 9-cis beta-carotene on retinal function of fundus albipunctatus
Date of disclosure of the study information 2015/05/25
Last modified on 2019/03/09

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Basic information
Public title Effect of 9-cis beta-carotene on retinal function of fundus albipunctatus
Acronym Effect of 9-cis beta-carotene on fundus albipunctatus
Scientific Title Effect of 9-cis beta-carotene on retinal function of fundus albipunctatus
Scientific Title:Acronym 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
1st name
Middle name
Last name Mineo Kondo
Organization Mie University School of Medicine
Division name Ophthalmology
Zip code
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
1st name
Middle name
Last name Mineo Kondo
Organization Mie University School of Medicine
Division name Ophthalmology
Zip code
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)

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 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

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 Completed
Date of protocol fixation
2015 Year 05 Month 07 Day
Date of IRB
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

Other
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

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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