UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000635 |
|---|---|
| Receipt number | 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 16:14:54 |
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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
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
obana@sis.seirei.or.jp
Sponsor or person
Institute
Raman Study Team
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000769
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