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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030606
Receipt No. R000034928
Scientific Title Trial for Visual function with oral Dunaliella・bardawil
Date of disclosure of the study information 2017/12/31
Last modified on 2019/05/29

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Basic information
Public title Trial for Visual function with oral Dunaliella・bardawil
Acronym The Dunaliella bardawil in patient with Visual function.
Scientific Title Trial for Visual function with oral Dunaliella・bardawil
Scientific Title:Acronym The Dunaliella bardawil in patient with Visual function.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The Dunaliella bardawil in patient with Visual function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Questionnaire on visual function 4 weeks after ingestion.
Visual Analogue Scale(VAS)
Key secondary outcomes Corrected visual acuity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 4 weeks Dunaliella intake
Interventions/Control_2 4 weeks placebo intake
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

Not applicable
Gender Male and Female
Key inclusion criteria Japanese
Participants in Matsumoto University
Key exclusion criteria histry using of the beta-carotene
smoker
subjects without informed consent
Target sample size 60

Research contact person
Name of lead principal investigator
1st name kazuhiro
Middle name
Last name Yanai
Organization Matsumoto University
Division name Department of Health and Nutrition Science
Zip code 390-1295
Address 2095-1, Niimura, Matsumoto, Nagano 390-1295
TEL 0263-48-7200
Email kazuhiro.yanai@matsu.ac.jp

Public contact
Name of contact person
1st name Kazuhiro
Middle name
Last name Yanai
Organization Matsumoto University
Division name Department of Health and Nutrition Science
Zip code 390-1295
Address 2095-1, Niimura, Matsumoto, Nagano 390-1295
TEL 0263-48-7200
Homepage URL
Email kazuhiro.yanai@matsu.ac.jp

Sponsor
Institute Matsumoto University
Department of Health and Nutrition Science
Institute
Department

Funding Source
Organization Nikken sohonsha corporation



Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Matsumoto University
Address 2095-1, Niimura, Matsumoto, Nagano 390- 1295
Tel 0263-48-7200
Email daisuke.ishikawa@matsu.ac.jp

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 松本大学(長野県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Jpn Pharmacol Ther vol.46 no.9(2018)
The effect of beta-caroten derived from 
microalga Dunaliella bardawil intake on 
Japanese visual function
-Random double-bind placebo comparision study-  
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
2017 Year 11 Month 01 Day
Date of IRB
2017 Year 07 Month 20 Day
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 01 Month 31 Day
Date trial data considered complete
2018 Year 01 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 28 Day
Last modified on
2019 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034928

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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