Thyroid Gland Dysfunction and Vitamin D Polymorphism in Keratoconus

Keratoconus Clinical Trial

Official title:

Thyroid Gland Dysfunction and Vitamin D Receptor Polymorphism in Keratoconus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05073601
• Other study ID #: R.21.01.1157.R1
• Status: Completed
• Start date: March 6, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: October 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: September 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

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

Locations

Country	Name	City	State
Egypt	Eman Azmy	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentration of free T3	pg/ml	2month
Primary	concentration of free T4	ng/dl	2 month
Primary	concentration of TSH	milli-international units per liter	2 month
Primary	vitamin D receptor polymorphism	number of participant with vitamin D receptor polymorphism	2 month
Secondary	serum vit D	concentration of Serum 25 OH vitamin D (ng /ml)	2 month