UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048971 |
|---|---|
| Receipt number | R000055460 |
| Scientific Title | The relationship between thyroid function and growth in Japanese children with congenital hypothyroidism: A retrospective cohort study |
| Date of disclosure of the study information | 2022/09/20 |
| Last modified on | 2023/10/23 23:06:37 |
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Basic information
Public title
The relationship between thyroid function and growth in Japanese children with congenital hypothyroidism
Acronym
The relationship between thyroid function and growth in Japanese children with congenital hypothyroidism
Scientific Title
The relationship between thyroid function and growth in Japanese children with congenital hypothyroidism: A retrospective cohort study
Scientific Title:Acronym
The relationship between thyroid function and growth in Japanese children with congenital hypothyroidism: A retrospective cohort study
Region
| Japan |
Condition
Condition
congenital hypothyroidism
Classification by specialty
| Endocrinology and Metabolism | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research aims to investigate the association between the severity of hypothyroidism and the age of adiposity rebound and young adult BMI in Japanese children with congenital hypothyroidism.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between congenital hypothyroidism and young adult obesity.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The age of adiposity rebound in Japanese children with congenital hypothyroidism
Key secondary outcomes
BMI at 15-18 years
Thyroid function at newborn screening, the first visit, and the initiation of treatment
Initial levothyroxine dose
Distal femoral epiphysis at the first visit
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People over 10years with congenital hypothyroidism detected by newborn screening and treated by levothyroxine natrium
Key exclusion criteria
People who refuse to participate in the study
People who were born with a birth weight under 2,000g
People with some malformation syndrome
People received replacement therapy other than thyroid hormone
Central hypothyroidism
People who are judged by their physicians in charge to be ineligible for any reason
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Akie |
| Middle name | |
| Last name | Nakamura |
Organization
Hokkaido Univerisity Hospital
Division name
Department of Pediatrics
Zip code
060-8638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5954
nakamura-ake@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Nakayama |
Organization
Hokkaido Univerisity Hospital
Division name
Department of Pediatrics
Zip code
060-8638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5954
Homepage URL
kananaka-ped@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sapporo Medical University
Tokyo Metropolitan Children's Medical Center
Niigata University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2022 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2020 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively evaluated the relationship between thyroid function and adiposity rebound which is related to adult obesity in Japanese congenital hypothyroidism children.
Management information
Registered date
| 2022 | Year | 09 | Month | 20 | Day |
Last modified on
| 2023 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055460
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
