UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004754
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email s.mitiyuki@gmail.com

Sponsor
Institute Hokkaido University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005660

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.