Thyroid Gland Dysfunction and Vitamin D Polymorphism in Keratoconus

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

Study Overview

• Status: Completed
• Conditions: Keratoconus
• Intervention / Treatment: Diagnostic test: ELISA,DNA extraction

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 Type: Observational
• Enrollment (Actual): 262

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Eman Azmy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

outpatient clinic of Mansoura ophthalmic center

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control group; group of subjects with healthy cornea	Diagnostic test: 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
keratoconus group; group of keratoconus patients with no history of thyroid dysfunction	Diagnostic test: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Eman Azmy, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 17, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Vitamin D; Polymorphism; keratoconus; Thyroid dysfunction
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: R.21.01.1157.R1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No