Thyroid Gland Dysfunction and Vitamin D Polymorphism in Keratoconus

NCT05073601 | Completed

• 1 other identifier: R.21.01.1157.R1
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study the thyroid gland dysfunction and vitamin D receptor polymorphism in keratoconus patients

Conditions

Keratoconus

Keywords

Thyroid dysfunction; Vitamin D; Polymorphism; keratoconus

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• serum vit D

  2 month

Study Arms (2)

control group

group of subjects with healthy cornea

Diagnostic Test: ELISA,DNA extraction

keratoconus group

group of keratoconus patients with no history of thyroid dysfunction

Diagnostic Test: ELISA,DNA extraction

Interventions

ELISA,DNA extraction 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

control group; keratoconus group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

outpatient clinic of Mansoura ophthalmic center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Eman Azmy

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

5ml venous blood was withdrawn from all subjects included in the study; 2ml on ethylenediamine tetraacetic acid (EDTA) for genetic study and 3ml on a plain tube for thyroid hormones and serum 25-(OH) vitamin D measurement. The blood samples for hormonal assessment were centrifuged then serum samples were stored at --20°C till analysis

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Eman Azmy

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 11, 2021
• Study Start: March 6, 2021
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

EG (1)