UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011512
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email shigeto-tky@umin.ac.jp

Sponsor
Institute The department of Ophthalmology, School of medicine, The university of tokyo
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013392

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.