Thyroid Gland Dysfunction and Vitamin D Polymorphism in Keratoconus

Study Overview
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Brief Summary
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This prospective study the thyroid gland dysfunction and vitamin D receptor polymorphism in keratoconus patients

Detailed Description
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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.

Official Title
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Thyroid Gland Dysfunction and Vitamin D Receptor Polymorphism in Keratoconus

Conditions
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Keratoconus

Intervention / Treatment
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* Diagnostic Test: ELISA,DNA extraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control group<br>group of subjects with healthy cornea | Diagnostic Test: ELISA,DNA extraction<br>* 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<br>|
| keratoconus group<br>group of keratoconus patients with no history of thyroid dysfunction | Diagnostic Test: ELISA,DNA extraction<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of free T3 | pg/ml | 2month | 
| concentration of free T4 | ng/dl | 2 month | 
| concentration of TSH | milli-international units per liter | 2 month | 
| vitamin D receptor polymorphism | number of participant with vitamin D receptor polymorphism | 2 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum vit D | concentration of Serum 25 OH vitamin D (ng /ml) | 2 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid dysfunction, Vitamin D, Polymorphism, keratoconus