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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000635
Receipt No. R000000769
Scientific Title Efficacy of lutein supplement on macular pigments density and visual performance of age-related macular degeneration (AMD) patients
Date of disclosure of the study information 2007/03/11
Last modified on 2009/09/11

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Basic information
Public title Efficacy of lutein supplement on macular pigments density and visual performance of age-related macular degeneration (AMD) patients
Acronym Efficacy of lutein supplement on age-related macular degeneration
Scientific Title Efficacy of lutein supplement on macular pigments density and visual performance of age-related macular degeneration (AMD) patients
Scientific Title:Acronym Efficacy of lutein supplement on age-related macular degeneration
Region
Japan

Condition
Condition age-related macular degeneration (AMD) patients
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will measure the macular pigment density and the change of visual functions after administration of lutein supplements on age-related macular degeneration patients, and evaluate the therapeutic effects of lutein for age-related macular degeneration.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Measurements of visual acuity, contrast sensitivity, metamorphopsia graded by M-chart, perimetric mean sensitivity, and macular pigment density
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 One capsule containing 10 mg of lutein and 0.8 mg of zeaxanthin is administered to each participants once a day for 12 months
Interventions/Control_2 One capsule of placebo supplement is administered to each participants once a day for 12 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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients having either early age-related maculopathy (ARM), exudative age-related macular degeneration (AMD), or atrophic AMD
(2) Patients showing either visual acuity of less than 1.0, decreased contrast sensitivity, metamorphopsia detected by M-cahrt, or decreased perimetric mean sensitivity measured by Humphry visual field analyzer (program 10-2)
(3) Patients aged 50-year-old or more and can sign an informed consent form for participation of this study
(4) Patients whom the principal investigator judges competent
(5) Patients with no lutein allergy
Key exclusion criteria (1) Eyes with cataract that affect the measurement of visual function tests.
(2) Eyes received cataract surgery within six months
(3) Eyes with glaucoma, diabetic retinopathy and any other eye disease
(4) Patient with serious disease in liver, kidney or heart that impacts on the evaluation of the use of lutein supplements
(5) Patient who is taking photosensitive medicine, such as phenothiazine, chloroquine or tetracycline
(6) Patient who involved in the other clinical trials within three months
(7) Others. Patients whom the principal investigator judges incompetent
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Obana, MD, PhD
Organization Seirei Hamamatsu General Hospital
Division name Department of Ophthalmology
Zip code
Address 2-12-12 Sumiyoshi, Hamamatsu, Shizuoka, 430-8558, Japan
TEL 053-430-2222
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akira Obana, MD, PhD
Organization Seirei Hamamatsu General Hospital
Division name Department of Ophthalmology
Zip code
Address 2-12-12 Sumiyoshi, Hamamatsu, Shizuoka, 430-8558, Japan
TEL 053-430-2222
Homepage URL
Email obana@sis.seirei.or.jp

Sponsor
Institute Raman Study Team
Institute
Department

Funding Source
Organization Seirei Hamamatsu General Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) Kemin Japan, Koyo Mercantile Co., LTD

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
2007 Year 03 Month 11 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
2006 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date
2007 Year 03 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 09 Month 01 Day
Date trial data considered complete
2009 Year 09 Month 01 Day
Date analysis concluded
2010 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 03 Month 11 Day
Last modified on
2009 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000769

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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