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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001320
Receipt No. 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

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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
Email

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
Email fgomi@ophthal.med.osaka-u.ac.jp

Sponsor
Institute Dept of Ophthalmology, Osaka University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001607

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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