UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001320 |
|---|---|
| Receipt number | R000001607 |
| Scientific Title | macular pigment optical density in Japanese age-related macular degeneration and the effect of lutein intake |
| Date of disclosure of the study information | 2009/01/01 |
| Last modified on | 2012/02/21 09:10:12 |
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Basic information
Public title
macular pigment optical density in Japanese age-related macular degeneration and the effect of lutein intake
Acronym
macular pigment density in Japanese
Scientific Title
macular pigment optical density in Japanese age-related macular degeneration and the effect of lutein intake
Scientific Title:Acronym
macular pigment density in Japanese
Region
| Japan |
Condition
Condition
eyes with or without macular disorder
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evalute the macular pigment density in Japanese and compare the result between age, the presence of macular disorder, or smoking history.
The time course of macular pigment density after the intake of lutein is also evaluated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the macular pigment optical density in Japanese with or without macular disorders.
the change of macular pigment optical density after lutein intake.
Key secondary outcomes
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
lutein intake(6mg/day) for 1 year
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with maular disorder associated with age-related macular degeneration or normal volunteers enable for the examination of macular pigment density in at least one eye.
Key exclusion criteria
subjects unable for the examination of macular pigment density
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumi |
Organization
Osaka University Medical School
Division name
Dept of Ophthalmology
Zip code
Address
2-2, Yamadaoka, Suita
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Medical retina
Division name
Dept of Ophthalmology
Zip code
Address
TEL
Homepage URL
fgomi@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Dept of Ophthalmology, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Bausch&Lomb Japan
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
| 2009 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.springerlink.com/content/c823517r1m393418/
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
| 2008 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 18 | Day |
Last modified on
| 2012 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001607
