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Completed

NCT Number: NCT05073601

Thyroid Gland Dysfunction and Vitamin D Polymorphism in Keratoconus

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

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eman Azmy

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. concentration of free T3

    Time frame: 2month

    pg/ml

  2. concentration of free T4

    Time frame: 2 month

    ng/dl

  3. concentration of TSH

    Time frame: 2 month

    milli-international units per liter

  4. vitamin D receptor polymorphism

    Time frame: 2 month

    number of participant with vitamin D receptor polymorphism

Secondary outcomes

  1. serum vit D

    Time frame: 2 month

    concentration of Serum 25 OH vitamin D (ng /ml)

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Thyroid Gland Dysfunction and Vitamin D Receptor Polymorphism in Keratoconus

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 11, 2021
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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