Precocious PubertyNCT05338411
Effect of Exogenous Growth Hormone on Ocular Findings
An observational study of Precocious Puberty and Early Puberty, run by Isfahan University of Medical Sciences at 2 sites in Iran.
Trial summary
Body size and eye function play an essential role in adapting to the environment and human survival. Growth hormone is commonly recognized by its effect on the height of individuals; Although from an evolutionary perspective, the effects of growth hormone on eye development are more important. Read more about this study
- Who is it for?
- Ages 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Precocious Puberty, Early Puberty, Refraction Error
- How many people
- 90 participants
- Where
- 2 sitesIran
- Study dates
- 20 Mar 2022to 22 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study groups are children with early or precocious puberty referred to endocrine clinic of Imam Hossein Hospital in Isfahan, Iran. The control group will be selected from the children who visit at the health centers for routine examinations.
Who may be able to join
- Sample group (with early or precocious puberty):
- Children with precocious puberty based on Tanner classification
- Girls 4 to 10 years old
- Boys aged 4 to 11
- No known eye problems including: history of eye trauma, eye surgery 5- lack of family history of glaucoma or increased intraocular pressure
- 6. Lack of previous history of receiving growth hormone 7. Lack of systemic disease or known syndromes 8. Consent to participate in the study
Who cannot join
- Incidence of growth hormone adverse reactions leading to discontinuation of treatment
- Changing the patient's treatment plan during the study
- Ocular complications requiring treatment during the study
- Unwillingness of the patient to continue participating in the study
Trial locations and contacts
2 sites in 1 country.
Iran2 sites, 2 recruiting
- Recruiting
Isfahan University of Medical Sciences
Isfahan, +98
Mohsen Pourazizi, +983134452031, m.pourazizi@yahoo.com
- Recruiting
Isfahan Eye Research Center
Isfahan, 81746-73461
Mohsen Pourazizi, M.D., 00983134452036, m.pourazizi@med.mui.ac.ir
About this study
Official title: Effect of Exogenous Growth Hormone on Ocular Findings of Children With Precocious and Early Puberty: a Prospective Cohort Study
Body size and eye function play an essential role in adapting to the environment and human survival. Growth hormone is commonly recognized by its effect on the height of individuals; Although from an evolutionary perspective, the effects of growth hormone on eye development are more important. Although the effect of growth hormone on eye development has not been accurately determined, the results of a number of studies suggest the effect of growth hormone on eye development.
Despite the large number of studies that have investigated the effects of growth hormone on height growth, there are few studies that have investigated the effects of growth hormone on the eye.
To the best of our knowledge, no study has been conducted to investigate the effect of growth hormone on ocular findings of patients with early or precocious puberty. Therefore, we intend to investigate the effect of growth hormone on ocular findings of patients with early or precocious puberty.
Read the detailed description
Investigators will achieve the following data from the participants:
- Demographics
- Past medical history
- Bone and calendar age
4- Stage of puberty
5- Ocular examination
- Ocular biometry
- Conditions
- Precocious Puberty, Early Puberty, Refraction Error
- Keywords
- Precocious Puberty, Early Puberty, human growth hormone, Refraction Error, Axial Length
- Medical subject headings
- Puberty, Precocious, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early or precocious puberty who receive GH | Children with early or precocious puberty who receive exogenous growth hormone | |
| Early or precocious puberty who does not receive GH | Children with early or precocious puberty who does not receive exogenous growth hormone | |
| Healthy | Healthy children without any past medical history |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refraction Error
Comparison of the refraction error between the study groups
Measured: 6 months
Axial Length
Comparison of the axial length between the study groups
Measured: 6 months
Secondary outcomes (2)
Papillitis
Comparison of the frequency of papillitis between the study groups
Measured: 6 months
Central Corneal Thickness
Comparison of the mean central corneal thickness between the study groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start20 Mar 2022
- Primary completion22 Oct 2023 (estimated)
- Study completion22 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precocious PubertyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohsen Pourazizi, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338411
- Sponsor's protocol ID
- IR.ARI.MUI.REC.1400.121
- Status last verified
- Apr 2022
- First submitted
- 10 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exogenous Growth Hormone on Ocular Findings of Children With Precocious and Early Puberty: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05338411
- Acronym / sponsor ID
- IR.ARI.MUI.REC.1400.121
- Conditions
- Precocious Puberty, Early Puberty, Refraction Error
- Keywords
- Precocious Puberty, Early Puberty, human growth hormone, Refraction Error, Axial Length
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 22 Oct 2023 (estimated)
- Study completion
- 22 Oct 2023 (estimated)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Body size and eye function play an essential role in adapting to the environment and human survival. Growth hormone is commonly recognized by its effect on the height of individuals; Although from an evolutionary perspective, the effects of growth hormone on eye development are more important. Although the effect of growth hormone on eye development has not been accurately determined, the results of a number of studies suggest the effect of growth hormone on eye development.
Despite the large number of studies that have investigated the effects of growth hormone on height growth, there are few studies that have investigated the effects of growth hormone on the eye.
To the best of our knowledge, no study has been conducted to investigate the effect of growth hormone on ocular findings of patients with early or precocious puberty. Therefore, we intend to investigate the effect of growth hormone on ocular findings of patients with early or precocious puberty.
Detailed description
Investigators will achieve the following data from the participants:
- Demographics
- Past medical history
- Bone and calendar age
4- Stage of puberty
5- Ocular examination
- Ocular biometry
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early or precocious puberty who receive GH | – | –Children with early or precocious puberty who receive exogenous growth hormone |
| Early or precocious puberty who does not receive GH | – | –Children with early or precocious puberty who does not receive exogenous growth hormone |
| Healthy | – | –Healthy children without any past medical history |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study groups are children with early or precocious puberty referred to endocrine clinic of Imam Hossein Hospital in Isfahan, Iran. The control group will be selected from the children who visit at the health centers for routine examinations.
Key inclusion criteria (6 listed)
- Children with precocious puberty based on Tanner classification
- Girls 4 to 10 years old
- Boys aged 4 to 11
- No known eye problems including: history of eye trauma, eye surgery 5- lack of family history of glaucoma or increased intraocular pressure
- 6. Lack of previous history of receiving growth hormone 7. Lack of systemic disease or known syndromes 8. Consent to participate in the study
Key exclusion criteria (4 listed)
- Incidence of growth hormone adverse reactions leading to discontinuation of treatment
- Changing the patient's treatment plan during the study
- Ocular complications requiring treatment during the study
- Unwillingness of the patient to continue participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Refraction Error
Time frame: 6 months
Comparison of the refraction error between the study groups
Axial Length
Time frame: 6 months
Comparison of the axial length between the study groups
2 secondary outcomes
Papillitis
Time frame: 6 months
Central Corneal Thickness
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Precocious Puberty and Early Puberty, run by Isfahan University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohsen Pourazizi, MD (00983134452036, m.pourazizi@med.mui.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refraction Error (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.