UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025635 |
|---|---|
| Receipt number | R000029418 |
| Scientific Title | The effectiveness of lutein in high myopic patients |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2020/07/16 17:53:22 |
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Basic information
Public title
The effectiveness of lutein in high myopic patients
Acronym
Lutein and high myopia
Scientific Title
The effectiveness of lutein in high myopic patients
Scientific Title:Acronym
Lutein and high myopia
Region
| Japan |
Condition
Condition
high myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study if orally administration of lutein could improve visual functions such as visual acuity, ERG, concentration of macular pigmentation, contrast sensitivity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The study of contrast sensitivity at baseline, 3-month and 6-month from baseline.
Key secondary outcomes
The study of visual acuity, concentration of macular pigmentation and ERG at baseline, 3-month and 6-month from baseline.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Lutein administration group .
Oral administration of Lutein 1capsule (20mg/capsule ) per day for 6 months
Interventions/Control_2
Placebo administration group .
Oral administration of sunflower oil 1capsule (180mg/capsule ) per day for 6 months
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
high myopia patients
Key exclusion criteria
Patients who have serious retinal diseases such as glaucoma, age related macular degeneration and bleeding.
Patients who have severe kidney disease , heart failure and hepatitis.
People who have taken administration of lutein in 6 months.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Ohno |
Organization
Tokyo Medical and Dental University
Division name
Ophthalmology
Zip code
1138519
Address
0358035302
TEL
0358035302
k.ohno.oph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yoshida |
Organization
Tokyo Medical and Dental University
Division name
Ophthalmology
Zip code
1138519
Address
Bunkyoku Yushida 1-5-45
TEL
0358035302
Homepage URL
takec.oph@tmd.ac.jp
Sponsor or person
Institute
Department of Ophthalmology,
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Santen pharmaceutical company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
Tokyo Medical and Dental University
Tel
0338136111
syomu1.adm@tmd.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 12 | Day |
Last modified on
| 2020 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029418
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| Registered date | File name |
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