UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030003 |
|---|---|
| Receipt number | R000034263 |
| Scientific Title | Hue Healthy Adolescents Cohort Study: Promotion of healthy vision and prevention of non-communicable diseases |
| Date of disclosure of the study information | 2017/11/16 |
| Last modified on | 2022/03/21 11:40:22 |
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Basic information
Public title
Hue Healthy Adolescents Cohort Study: Promotion of healthy vision and prevention of non-communicable diseases
Acronym
Hue Adolescents Healthy Vision Cohort Study
Scientific Title
Hue Healthy Adolescents Cohort Study: Promotion of healthy vision and prevention of non-communicable diseases
Scientific Title:Acronym
Hue Adolescents Healthy Vision Cohort Study
Region
| Asia(except Japan) |
Condition
Condition
Myopia, Non-communicable diseases
Classification by specialty
| Pediatrics | Ophthalmology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the risk factors of refractive errors, obesity and underweight in adolescents in Hue, Vietnam.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Status of refractive error and its changes in 36 months
Key secondary outcomes
Body Mass Index (BMI) and changes of BMI in 36 months
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Examination of visual acuity, refractive errors, axial length, height and weight at one day at the initial contact.
Interventions/Control_2
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
| 11 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The first grade student in a secondary school
Be able to communicate with and read in Vietnamese
Submission of informed consent and assent
Key exclusion criteria
Student absent on the exanination day
Student who didn't agree to join the study
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Nakamura |
Organization
Tokyo Medical and Dental University
Division name
Department of Global Health Entrepreneurship
Zip code
113-8519
Address
Tokyo
TEL
03-5803-4048
nakamura.ith@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Nakamura |
Organization
Tokyo Medical and Dental University
Division name
Department of Global Health Entrepreneurship
Zip code
113-8519
Address
Tokyo
TEL
03-5803-4048
Homepage URL
nakamura.ith@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Grants in Aid for Scientific Research, Japan Society for Promotion of Science, MEXT, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hue University of Medicine and Pharmacy
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University, Faculty of Medicine, IRB
Address
Yushima 1-5-45, Bunkyo-ku
Tel
03-3813-6111
syomu1.adm@tmd.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
Nguyen Chi Dieu Secondary School (Hue, Vietnam), Truong THCS Nguyen Thi Minh Khai Secondary School (Hue, Vietnam), Thong Nhat Secondary School (Hue, Vietnam), Ham Nghi Secondary School (Hue, Vietnam), Nguyen Du Secondary School (Hue, Vietnam)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 16 | 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
648
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
| 2017 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2022 | 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
| 2017 | Year | 11 | Month | 16 | Day |
Last modified on
| 2022 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034263
