UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027962 |
|---|---|
| Receipt number | R000028362 |
| Scientific Title | Randomized parallel-group trial of lutein supplementation for macular pigment optical density and visual function in the patients with unilateral age-related macular degeneration |
| Date of disclosure of the study information | 2017/06/28 |
| Last modified on | 2018/10/15 09:53:03 |
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Basic information
Public title
Randomized parallel-group trial of lutein supplementation for macular pigment optical density and visual function in the patients with unilateral age-related macular degeneration
Acronym
Randomized parallel-group trial of lutein supplementation in AMD
Scientific Title
Randomized parallel-group trial of lutein supplementation for macular pigment optical density and visual function in the patients with unilateral age-related macular degeneration
Scientific Title:Acronym
Randomized parallel-group trial of lutein supplementation in AMD
Region
| Japan |
Condition
Condition
Age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investtigate the efficacy of lutein supplementaion to the eyes with unilateral age-related macular degeneration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
macular pigment density, serum lutein concentration, contrast sensitivity at 3 months and 6 months after lutein intake.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
20mg Lutein supplemenation covered by beeswax
Interventions/Control_2
20mg Lutein supplemenation covered by glycerol ester
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
Fello eyes with unilateral age-related macular degeneration.
No fundus abnormality or age-related maculopathy
Key exclusion criteria
ocular media dicrepancy to disturb measuremant of macular pigment optical density.
high myopia
lutein intake within 3 months
lutein allergy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MIKI SAWA |
Organization
Sakai City Medical Center
Division name
Eye center
Zip code
Address
1-1-1 Ebaraji-cho, Nishi-ku, Sakai City, Osaka
TEL
072-272-1199
sawamikimd@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MIKI SAWA |
Organization
Sakai City Medical Center
Division name
Eye center
Zip code
Address
1-1-1 Ebaraji-cho, Nishi-ku, Sakai City, Osaka
TEL
072-272-1199
Homepage URL
sawamikimd@gmail.com
Sponsor or person
Institute
Sakai City Medical Center
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co.,LTD.
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 06 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 28 | Day |
Last modified on
| 2018 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028362
