KeratoconusNCT05073601
Thyroid Gland Dysfunction and Vitamin D Polymorphism in Keratoconus
An observational study of Keratoconus, run by Mansoura University at 1 site in Egypt.
Trial summary
This prospective study the thyroid gland dysfunction and vitamin D receptor polymorphism in keratoconus patients Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- ELISA,DNA extraction
- How many people
- 262 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Mar 2021to 1 Sep 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: outpatient clinic of Mansoura ophthalmic center
Who may be able to join
- keratoconus patients without previously diagnosed thyroid disorder in comparison to healthy control without known systemic disease and with normal cornea who were selected from candidates of refractive surgery with normal topography
Who cannot join
- patients who could not provide informed consent or the necessary samples for any reason, patients with associated other ophthalmic pathologies or systemic disorders were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thyroid Gland Dysfunction and Vitamin D Receptor Polymorphism in Keratoconus
This prospective study the thyroid gland dysfunction and vitamin D receptor polymorphism in keratoconus patients
Read the detailed description
This is a prospective observational study in which blood samples are collected from keratoconus patients looking for thyroid dysfunction and vitamin D levels in the serum and assessing the Vitamin D receptor polymorphism in comparison to healthy control.
- Conditions
- Keratoconus
- Being tested
- ELISA,DNA extraction
- Keywords
- Thyroid dysfunction, Vitamin D, Polymorphism, keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA,DNA extractionDiagnostic test
quantitative measurement of (Thyroid stimulating hormon (TSH), free triiodothyronine (FT3)\& Free tetraiodothyronine(FT4)) measured using ELISA . Serum 25-OH vitamin D measured using ELISA. Serum 25-OH vitamin D will be classified based on 2012 American Endocrine Society guidelines into deficient (< 20ng/ml), insufficient ( 21 -30 ng/ml) and sufficient (> 30 ng/ml).vitamin D receptor polymorphisms was done in 3 steps: a) DNA extraction from whole blood using Gene Jet gene DNA Purification kits . b) PCR: three Vitamin D receptor polymorphisms were tested [Taq I (restriction enzymes according to single nucleotide polymorphism ) (rs731236), Apa I (rs7975232) and Bsm I (rs1544410)] using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Genomic DNA was amplified using certain primers
| Study group | Role | What they receive |
|---|---|---|
| control group | group of subjects with healthy cornea Receives: Diagnostic Test: ELISA,DNA extraction | |
| keratoconus group | group of keratoconus patients with no history of thyroid dysfunction Receives: Diagnostic Test: ELISA,DNA extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of free T3
pg/ml
Measured: 2month
concentration of free T4
ng/dl
Measured: 2 month
concentration of TSH
milli-international units per liter
Measured: 2 month
vitamin D receptor polymorphism
number of participant with vitamin D receptor polymorphism
Measured: 2 month
Secondary outcomes (1)
serum vit D
concentration of Serum 25 OH vitamin D (ng /ml)
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start6 Mar 2021
- Primary completion1 Jul 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Azmy, Mansoura University
- Investigators
- Eman Azmy, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073601
- Sponsor's protocol ID
- R.21.01.1157.R1
- Status last verified
- Oct 2021
- First submitted
- 22 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Gland Dysfunction and Vitamin D Receptor Polymorphism in Keratoconus
- ClinicalTrials.gov ID
- NCT05073601
- Acronym / sponsor ID
- R.21.01.1157.R1
- Conditions
- Keratoconus
- Keywords
- Thyroid dysfunction, Vitamin D, Polymorphism, keratoconus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 6 Mar 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 11 Oct 2021 (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.
This prospective study the thyroid gland dysfunction and vitamin D receptor polymorphism in keratoconus patients
Detailed description
This is a prospective observational study in which blood samples are collected from keratoconus patients looking for thyroid dysfunction and vitamin D levels in the serum and assessing the Vitamin D receptor polymorphism in comparison to healthy control.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Diagnostic Test: ELISA,DNA extractiongroup of subjects with healthy cornea |
| keratoconus group | – | Diagnostic Test: ELISA,DNA extractiongroup of keratoconus patients with no history of thyroid dysfunction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient clinic of Mansoura ophthalmic center
Key inclusion criteria (1 listed)
- keratoconus patients without previously diagnosed thyroid disorder in comparison to healthy control without known systemic disease and with normal cornea who were selected from candidates of refractive surgery with normal topography
Key exclusion criteria (1 listed)
- patients who could not provide informed consent or the necessary samples for any reason, patients with associated other ophthalmic pathologies or systemic disorders were excluded from 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISA,DNA extractionquantitative measurement of (Thyroid stimulating hormon (TSH), free triiodothyronine (FT3)\& Free tetraiodothyronine(FT4)) measured using ELISA . Serum 25-OH vitamin D measured using ELISA. Serum 25-OH vitamin D will be classified based on 2012 American Endocrine Society guidelines into deficient (< 20ng/ml), insufficient ( 21 -30 ng/ml) and sufficient (> 30 ng/ml).vitamin D receptor polymorphisms was done in 3 steps: a) DNA extraction from whole blood using Gene Jet gene DNA Purification kits . b) PCR: three Vitamin D receptor polymorphisms were tested [Taq I (restriction enzymes according to single nucleotide polymorphism ) (rs731236), Apa I (rs7975232) and Bsm I (rs1544410)] using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Genomic DNA was amplified using certain primers | Diagnostic test | control group, keratoconus group |
Primary outcome
concentration of free T3
Time frame: 2month
pg/ml
concentration of free T4
Time frame: 2 month
ng/dl
concentration of TSH
Time frame: 2 month
milli-international units per liter
vitamin D receptor polymorphism
Time frame: 2 month
number of participant with vitamin D receptor polymorphism
1 secondary outcome
serum vit D
Time frame: 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
Eman Azmy principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of free T3 (time frame: 2month). The study lists 4 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 Oct 2021.