UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045613 |
|---|---|
| Receipt number | R000052076 |
| Scientific Title | Clinical trials on accommodation function of the eye by continuous intake of supplements. : A randomized, double blinded, placebo controlled, and parallel group comparison study. |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2023/04/06 09:22:28 |
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Basic information
Public title
Effect of the supplement on accommodation of eye. : A randomized, double blinded, placebo controlled, and parallel group comparison study.
Acronym
Effect of the supplement on accommodation of eye.
Scientific Title
Clinical trials on accommodation function of the eye by continuous intake of supplements. : A randomized, double blinded, placebo controlled, and parallel group comparison study.
Scientific Title:Acronym
Clinical trials on accommodation function of the eye by continuous intake of supplements.
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of continuous ingestion of test foods on the accommodation function of the eye.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accommodation of eye
Time: 0w, 4w
Key secondary outcomes
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
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test Food Low dose
Intervention period:4weeks
Interventions/Control_2
Test Food High dose
Intervention period:4weeks
Interventions/Control_3
Placebo
Intervention period:4weeks
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
| 30 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese male or female between the ages of 30 and 45
2. Subjects who spend a lot of time working on VDT per day
3. Subjects who have no eye disease other than refractive error (myopia, hyperopia, astigmatism)
4. Subjects who fully understand the purpose and content of this test and agree in writing
Key exclusion criteria
1. Pollen allergies (during the study period) or perennial allergic conjunctivitis
2. LASIK surgery within 6 months
3. History or complication of serious liver, kidney, cardiovascular, gastrointestinal, lung, blood, or metabolic serious diseases
4. Regularly use medicines when obtaining consent
5. Cannot stop taking supplements during the test period
6. Have drug or food allergy
7. Participated in other clinical trials within the past month
8. Pregnant, breastfeeding or wish to become pregnant
9. Cannot maintain their daily habits
10. Have plans for overseas trips and long-term business trips
11. Shift workers and late-night workers who work after 0:00 AM
12. Users of supplements that may affect this test.
13. Drinker more than 40 g/day of pure alcohol
14. Smoker (over 20 cigarettes / day)
15. Who cannot take the test food as instructed
16. Donor of blood components or >= 200 mL whole blood within 1 month before the start of the test
17. Who feel sick after collecting blood
18. Determined by the responsible doctor to be inappropriate for this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, JAPAN
TEL
0458203443
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Yoshiki |
| Middle name | |
| Last name | Endoh |
Organization
New drug research center, Inc.
Division name
Clinical Research Dept.
Zip code
061-1405
Address
452-1 Toiso, Eniwa-shi, Hokkaido, Japan
TEL
0123-34-0412
Homepage URL
y-endoh@ndrcenter.co.jp
Sponsor or person
Institute
New Drug Research Center,Inc.
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuhara Clinic Clinical Trial Review Committee
Address
Shimamatsuhigashimachi-3-chome, Eniwa-shi, Hokkaido
Tel
0123-36-8029
d-kameda@mediffom.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
福原医院（北海道）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 01 | 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
| 2021 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 30 | Day |
Last modified on
| 2023 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052076
