UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030606 |
|---|---|
| Receipt number | 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 16:50:38 |
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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
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
kazuhiro.yanai@matsu.ac.jp
Sponsor or person
Institute
Matsumoto University
Department of Health and Nutrition Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034928
| 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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| Registered date | File name |
