UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047137 |
|---|---|
| Receipt number | R000053769 |
| Scientific Title | The effect of test food intake on deterioration of visual function after VDT work |
| Date of disclosure of the study information | 2023/04/30 |
| Last modified on | 2023/02/22 18:22:05 |
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Basic information
Public title
The effect of test food intake on deterioration of visual function after VDT work
Acronym
The effect of test food intake on deterioration of visual function after VDT work
Scientific Title
The effect of test food intake on deterioration of visual function after VDT work
Scientific Title:Acronym
The effect of test food intake on deterioration of visual function after VDT work
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of test food intake on deterioration of visual function after VDT work
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual function
Key secondary outcomes
Macular pigment optical density
Quality of Life Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral intake of test foods
Interventions/Control_2
Oral intake of placebo foods
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1]Subjects with bilateral distant vision of 0.6 or higher (uncorrected or corrected)
[2]Subjects who routinely play TV games, use PC, or perform VDT
[3]Subjects who can have an examinations and obsevations as scheduled
[4] Subjects who received sufficient explanation about the purpose and content of the trial, had the ability to consent, volunteered to participate after understanding it well, and agreed to participate in the trial in writing
Key exclusion criteria
[1]Subjects who have medical history of serious diseases such as liver disease, renal disease, cardiovascular disease, gastrointestinal disease, respiratory disease, hematological disease, autoimmune disease, endocrine system disease, metabolic disease, etc
[2]Subjects who have a history of drug allergy or serious food allergy
[3]Subjects who continuously used medicines, health foods or supplements that could affect this study
[4]Subjects who are judged by the investigator to be inappropriate for the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Sakai |
Organization
Senju Pharmaceutical Co., Ltd
Division name
New Business Creation and Development
Zip code
541-0048
Address
3-1-9, Kawara-machi, Chuo-Ku, Osaka Japan
TEL
06-6201-9610
osamu-sakai@senju.co.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Yoshida |
Organization
Senju Pharmaceutical Co., Ltd
Division name
New Business Creation and Development
Zip code
541-0048
Address
3-1-9, Kawara-machi, Chuo-Ku, Osaka Japan
TEL
06-6201-9610
Homepage URL
k-yoshida@senju.co.jp
Sponsor or person
Institute
Senju Pharmaceutical Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2 Gokanmachi Maebashi-shi Gunma
Tel
027-261-7600
sagawa@mc-connect.co.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 30 | 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
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 10 | Day |
Last modified on
| 2023 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053769
