UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005849 |
|---|---|
| Receipt number | R000006910 |
| Scientific Title | Effectiveness for macular pigment with lutein supplementation in central serous chorioretinopathy |
| Date of disclosure of the study information | 2011/06/26 |
| Last modified on | 2014/07/01 10:15:13 |
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Basic information
Public title
Effectiveness for macular pigment with lutein supplementation in central serous chorioretinopathy
Acronym
Effectiveness for macular pigment with lutein supplementation in central serous chorioretinopathy
Scientific Title
Effectiveness for macular pigment with lutein supplementation in central serous chorioretinopathy
Scientific Title:Acronym
Effectiveness for macular pigment with lutein supplementation in central serous chorioretinopathy
Region
| Japan |
Condition
Condition
Central serous chorioretinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess macular pigment and serum lutein with lutein supplementaiton in central serous chorioretinopathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
macular pigment and serum lutein
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
supplement with lutein
Interventions/Control_2
supplement without lutein
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Central serous chorioretinopathy eyes with subretinal fluid and leakage on fluorescein angiography
2)Japanese patient more than 30 years old
Key exclusion criteria
1)Hard exudate or subretinal hemorrhage within subretinal fluid
2)Invisible fundus
3)Visual acuity less than 0.01
4)Difficulty to measure macular pigment
5)After vitrectomy
6)Past supplementaion with lutein
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumi Gomi |
Organization
Osaka University
Division name
Ophthalmology
Zip code
Address
Yamadaoka 2-2, Suita, Osaka
TEL
06-6879-3456
fgomi@ophthal.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miki Sawa |
Organization
Osaka Univerisity Medical Hospital
Division name
Ophthalmology
Zip code
Address
Yamadaoka 2-2, Suita, Osaka
TEL
06-6879-3456
Homepage URL
sawamiki@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Osaka Univeristy Medical School
Institute
Department
Personal name
Funding Source
Organization
Santen
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
| 2011 | Year | 06 | Month | 26 | 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
In a 4-month placebo-controlled study with 20-mg lutein supplementation, macular pigment optical density (MPOD) did not increase in central serous chorioretinopathy (CSC). Lutein supplementation maintained the MPOD in CSC patients with low plasma lutein.
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
| 2011 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 26 | Day |
Last modified on
| 2014 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006910
