UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055654 |
|---|---|
| Receipt number | R000063605 |
| Scientific Title | Retinal and Choroidal Microvascular Assessment of Children Receiving Recombinant Growth Hormone Therapy. |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/09/28 01:47:10 |
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Basic information
Public title
Retinal and Choroidal Microvascular Assessment of Children Receiving Recombinant Growth Hormone Therapy.
Acronym
Retinal and Choroidal Microvascular Assessment of Children Receiving Recombinant GH Therapy.
Scientific Title
Retinal and Choroidal Microvascular Assessment of Children Receiving Recombinant Growth Hormone Therapy.
Scientific Title:Acronym
Retinal and Choroidal Microvascular Assessment of Children Receiving Recombinant Growth Hormone Therapy.
Region
| Africa |
Condition
Condition
observational study
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the retinal and choroidal microvascular state in children with congenital isolated growth hormone deficiency (IGHD) and to determine the effect of recombinant human growth hormone treatment on these structures compared with healthy controls
Basic objectives2
Others
Basic objectives -Others
OCT angiography study of the patients on GH therapy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compared to healthy individuals, children receiving recombinant growth hormone therapy showed no changes in the retinal and choroidal microvasculature or macular thickness
Key secondary outcomes
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
| 8 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Enrollment of the patients in the study was based on age equal to or less than 16 years old, and patients were not receiving any therapy other than recombinant GH for group 1, clear ocular media, and no history of chronic ocular or systemic diseases.
Key exclusion criteria
The patients were excluded from the study if they had a history of preterm or small-for-gestational-age birth, a diagnosis of cardiovascular disease, thyroid disease, hepatic or renal disorder, obesity, current hypertension, or the presence of chromosomal abnormalities. Also, the study did not include children with high myopia, hyperopia, amblyopia, or ocular disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ismail |
| Middle name | |
| Last name | Omar |
Organization
Minia University Hospital
Division name
Ophthalmology
Zip code
61111
Address
Minia university hospital, ophthalmology dept.,
TEL
+201002554116
ismail.omar@mu.edu.eg
Public contact
Name of contact person
| 1st name | Ismail |
| Middle name | |
| Last name | Omar |
Organization
Minia university hospital
Division name
Ophthalmology
Zip code
61111
Address
Minia university hospital, ophthalmology dept.,
TEL
+201002554116
Homepage URL
ismail.omar@mu.edu.eg
Sponsor or person
Institute
Faculty of medicine, Minia 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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Minia university hospital
Address
Minia university hospital, ophthalmology dept.,
Tel
+201002554116
ismail.omar@mu.edu.eg
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
| 2024 | Year | 10 | 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
60
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
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
patients were observed and examined with OCT angiography to evaluate the microvascular changes in patients on GH therapy
Management information
Registered date
| 2024 | Year | 09 | Month | 28 | Day |
Last modified on
| 2024 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063605
| 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 |
