Thyroid Gland Dysfunction and Vitamin D Polymorphism in Keratoconus
Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT05073601
Collaborator
(none)
262
1
5.9
44.6
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 |
---|---|---|
|
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
|
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:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eman Azmy,
assistant professor,
Mansoura University
Additional relevant MeSH terms: