Tokyo, Oct. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058930) titled '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' on Oct. 3.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Tamagawa University
Condition:
Condition - None (Healthy subjects)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effect of a dairy component on ophthalmic parameters.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake of a dairy component for 52 weeks.
Interventions/Control_2 - no treatment
Eligibility:
Age-lower limit - 6
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 Size - 200
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067388
Disclaimer: Curated by HT Syndication.
