UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011512 |
|---|---|
| Receipt number | R000013392 |
| Scientific Title | The clinical study for the effect of oral supplementary drugs containing lutein on macular pigment density |
| Date of disclosure of the study information | 2013/08/29 |
| Last modified on | 2014/08/20 14:51:10 |
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Basic information
Public title
The clinical study for the effect of oral supplementary drugs containing lutein on macular pigment density
Acronym
The effect of oral supplementary drug containing lutein on macular pigment density
Scientific Title
The clinical study for the effect of oral supplementary drugs containing lutein on macular pigment density
Scientific Title:Acronym
The effect of oral supplementary drug containing lutein on macular pigment density
Region
| Japan |
Condition
Condition
The patients with early age-related macular degeneration and healthy volunteer participants
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of daily supplementary tablets containing lutein, on several kind of visual functions, and to find out the appropriate way to measure the macular pigment optical densities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
macular pigment optical density, serum consentration of lutein and some other amino acids, contrast sensitivity, best corrected visua acuities.
Key secondary outcomes
Base
Study type
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
daily dose with supplementary tablets which contains lutein 20mg, for 6 months.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with early age-related macular degeneration: one or more indistinct soft drusen at macular area, or distinct soft drusen(s) with pigment epithelial abnormality.
healthy volunteer participants: healthy adults in age between 20 and 61 year old.
Key exclusion criteria
patients with early age-related macular degeneration: patients with cataract which could prevent clear fundus autofluorescent image. patients with some kinds of systemic disease which could cause macular abnormality.
healthy volunteer participants: who is affected with some kinds of dieases which could cause macular abnormalities, pregnant, possibly pregnant.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yasuo yanagi |
Organization
the university of tokyo hospital
Division name
dapartment of ophthalmology
Zip code
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL
0338155411
yanagi-tky@umin.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeto Fujimura |
Organization
the university of tokyo hospital
Division name
The department of ophthalmology
Zip code
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL
0338155411
Homepage URL
shigeto-tky@umin.ac.jp
Sponsor or person
Institute
The department of Ophthalmology, School of medicine, The university of tokyo
Institute
Department
Personal name
Funding Source
Organization
Santen pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 29 | 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
| 2013 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 03 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 20 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 20 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 20 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 18 | Day |
Last modified on
| 2014 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013392
