UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004754 |
|---|---|
| Receipt number | R000005660 |
| Scientific Title | The randomized, pracedo-controlled, double brind crinical trial for the choroidal circulation of 12mg astaxanthin ingestion. |
| Date of disclosure of the study information | 2010/12/20 |
| Last modified on | 2010/12/20 10:34:11 |
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Basic information
Public title
The randomized, pracedo-controlled, double brind crinical trial for the choroidal circulation of 12mg astaxanthin ingestion.
Acronym
The crinical trial for the choroidal circulation of 12mg astaxanthin ingestion.
Scientific Title
The randomized, pracedo-controlled, double brind crinical trial for the choroidal circulation of 12mg astaxanthin ingestion.
Scientific Title:Acronym
The crinical trial for the choroidal circulation of 12mg astaxanthin ingestion.
Region
| Japan |
Condition
Condition
choroidal circulation disorder
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the change of choroidal circulation for the astaxanthin ingestion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The choroidal circulation, the mean blur rate measured by laser speckle flowgraphy, at 4 weeks after the initiation of ingestion.
Key secondary outcomes
The choroidal circulation, the mean blur rate measured by laser speckle flowgraphy, at 2 and 4 weeks after the initiation of ingestion and the conplications.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The 12mg astaxanthin capsules ingestion for 4 weeks.
Interventions/Control_2
The placebo capsules ingestion for 4 weeks.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healty subjects
Key exclusion criteria
The subjects who were pregnant or any systemic or ocular abnormalities were found.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Yoshida |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Ocular inflammation and Immunology
Zip code
Address
Nishi-7-chome, Kita 15-jou, Kita-ku, Sapporo 060-8638, Japan
TEL
+81-11-706-5944
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiyuki Saito |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Ocular inflammation and Immunology
Zip code
Address
Nishi-7-chome, Kita 15-jou, Kita-ku, Sapporo 060-8638, Japan
TEL
+81-11-706-5944
Homepage URL
s.mitiyuki@gmail.com
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ocular inflammation and Immunology, Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
Hokkaido University Hospital
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 20 | 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
| 2007 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 20 | Day |
Last modified on
| 2010 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005660
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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