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Thyroid Gland Dysfunction and Vitamin D Polymorphism in Keratoconus

NCT ID: NCT05073601

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

262 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-06

Study Completion Date

2021-09-01

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.

Conditions

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Keratoconus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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control group

group of subjects with healthy cornea

ELISA,DNA extraction

Intervention Type DIAGNOSTIC_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

keratoconus group

group of keratoconus patients with no history of thyroid dysfunction

ELISA,DNA extraction

Intervention Type DIAGNOSTIC_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

Interventions

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ELISA,DNA extraction

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

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Eman Azmy

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eman Azmy

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Eman Azmy

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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R.21.01.1157.R1

Identifier Type: -

Identifier Source: org_study_id