Thyroid Gland Dysfunction and Vitamin D Polymorphism in Keratoconus

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT05073601

Collaborator

(none)

262

Enrollment

Location

5.9

Actual Duration (Months)

44.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Keratoconus	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 Design

Study Type:

Observational

Actual Enrollment :

262 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Thyroid Gland Dysfunction and Vitamin D Receptor Polymorphism in Keratoconus

Actual Study Start Date :

Mar 6, 2021

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

concentration of free T3 [2month]
pg/ml
concentration of free T4 [2 month]
ng/dl
concentration of TSH [2 month]
milli-international units per liter
vitamin D receptor polymorphism [2 month]
number of participant with vitamin D receptor polymorphism

Secondary Outcome Measures

serum vit D [2 month]
concentration of Serum 25 OH vitamin D (ng /ml)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eman Azmy	Mansoura	Dakahlia	Egypt	35511

Sponsors and Collaborators

Mansoura University

Investigators

Principal Investigator: Eman Azmy, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eman Azmy, assistant professor, Mansoura University

ClinicalTrials.gov Identifier:

NCT05073601

Other Study ID Numbers:

R.21.01.1157.R1

First Posted:

Oct 11, 2021

Last Update Posted:

Oct 21, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Eman Azmy, assistant professor, Mansoura University

Additional relevant MeSH terms:

Keratoconus

Study Results

No Results Posted as of Oct 21, 2021