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Thyroid Gland Dysfunction and Vitamin D Polymorphism in Keratoconus

Thyroid Gland Dysfunction and Vitamin D Receptor Polymorphism in Keratoconus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05073601
Enrollment
262
Registered
2021-10-11
Start date
2021-03-06
Completion date
2021-09-01
Last updated
2021-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

Thyroid dysfunction, Vitamin D, Polymorphism, keratoconus

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTELISA,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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
concentration of free T32monthpg/ml
concentration of free T42 monthng/dl
concentration of TSH2 monthmilli-international units per liter
vitamin D receptor polymorphism2 monthnumber of participant with vitamin D receptor polymorphism

Secondary

MeasureTime frameDescription
serum vit D2 monthconcentration of Serum 25 OH vitamin D (ng /ml)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026