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UMIN-CTR Clinical Trial |
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Name: | 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 |
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 |
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Condition | ||
Condition | Fundus albipunctatus | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |