UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017676 |
|---|---|
| Receipt number | 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 09:03:38 |
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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
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
mineo@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020490
