UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058930 |
|---|---|
| Receipt number | R000067388 |
| Scientific Title | Effects of a dairy component on ophthalmic parameters of children in an elementary school: a randomized, open-label, parallel-group trial with a no treatment control group. |
| Date of disclosure of the study information | 2025/10/03 |
| Last modified on | 2025/08/29 06:25:06 |
* 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
Effects of a dairy component on ophthalmic parameters of children in an elementary school: a randomized, open-label, parallel-group trial with a no treatment control group.
Acronym
Effect of a dairy component on ophthalmic parameters of children.
Scientific Title
Effects of a dairy component on ophthalmic parameters of children in an elementary school: a randomized, open-label, parallel-group trial with a no treatment control group.
Scientific Title:Acronym
Effect of a dairy component on ophthalmic parameters of children.
Region
| Japan |
Condition
Condition
None (Healthy subjects)
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of a dairy component on ophthalmic parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ophthalmic parameters
Key secondary outcomes
Ophthalmic parameters
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of a dairy component for 52 weeks.
Interventions/Control_2
no treatment
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Elementary school students
2) Subjects aged 6-12 years (the first-sixth grade)
Key exclusion criteria
1) Subjects who regularly consume foods fortified with a dairy to be evaluated.
2) Subjects who are affected with ophthalmic diseases.
3) Subjects who are unable to undergo ophthalmic examinations without glasses or contact lenses.
4) Subjects who receive medical treatments or take medicines/functional foods during the pre-test and test periods, which can affect ophthalmic parameters.
5) Subjects who have serious disease in the liver, kidney heart, lung, gastrointestinal tract, blood, endocrine system, or metabolic system etc. Or those who have serious medical history of these.
6) Subjects having a milk allergy.
7) Subjects who have medical history of drug allergy or severe food ones.
8) Others who have been determined as ineligible for the research subject of this study, judging from the principal researcher/doctor's opinions on the findings of their background, physical observations, medical checkup, biochemical and clinical tests, and so on.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Tomita |
Organization
Tamagawa University
Division name
Department of Advanced Food Sciences, Faculty of Agriculture
Zip code
194-8610
Address
6-1-1 Tamagawa Gakuen, Machida, Tokyo, Japan
TEL
042-739-8267
shinichi@agr.tamagawa.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Tomita |
Organization
Tamagawa University
Division name
Department of Advanced Food Sciences, Faculty of Agriculture
Zip code
194-8610
Address
6-1-1 Tamagawa Gakuen, Machida, Tokyo, Japan
TEL
042-739-8267
Homepage URL
shinichi@agr.tamagawa.ac.jp
Sponsor or person
Institute
Tamagawa University
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry
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
Ethics committee of Tamagawa University
Address
6-1-1 Tamagawa Gakuen, Machida, Tokyo, Japan
Tel
042-739-8666
t.instit@adm.tamagawa.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2025 | Year | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067388
