- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02539745
Associations of Vitamin D Deficiency and Vitamin D Receptor Polymorphisms With the Risk of Primary Open-angle Glaucoma
April 21, 2016 updated by: Lv Yingjuan
This study investigated whether vitamin D receptor gene polymorphism is altered in primary open-angle glaucoma subjects carrying the risk allele and vitamin D deficiency is an important factor in the development of glaucoma.
Primary open-angle glaucoma patients and age-matched people in the Han population were enrolled.
Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by enzyme-linked immunoabsorbent assay.
Vitamin D receptor polymorphic analysis was studied by real-time polymerase-chain reaction high resolution melting analysis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tianjin
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Tianjin, Tianjin, China, 300384
- Tianjin Medical University Eye Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
primary open-angle glaucoma patients and randomly age-matched people as controls in the Han population of Tianjin China
Description
Inclusion Criteria:
- intraocular pressure greater than 22 mmHg with two or more medications
- wide anterior chamber angle
- glaucomatous optic neuropathy (Glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual field defect)
- visual field loss consistent with optic nerve damage and visual fields were performed by using standard automated perimetry
Exclusion Criteria:
- the presence of any secondary glaucoma including exfoliation syndrome or a history of ocular trauma
- high myopia
- macular degeneration
- other ocular diseases
- a known history of systemic diseases and administration of vitamin D3 or other analog
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
primary open-angle glaucoma patients
Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by enzyme-linked immunoabsorbent assay and vitamin D receptor polymorphic analysis was studied by real-time polymerase-chain reaction high resolution melting analysis in primary open-angle glaucoma patients.
|
Vitamin D receptor polymorphic analysis was studied by real-time polymerase-chain reaction high resolution melting analysis.
Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by enzyme-linked immunoabsorbent assay.
|
|
randomly age-matched people
Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by enzyme-linked immunoabsorbent assay and vitamin D receptor polymorphic analysis was studied by real-time polymerase-chain reaction high resolution melting analysis in randomly age-matched people.
|
Vitamin D receptor polymorphic analysis was studied by real-time polymerase-chain reaction high resolution melting analysis.
Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by enzyme-linked immunoabsorbent assay.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Serum levels of 1a, 25-Dihydroxyvitamin D3
Time Frame: 1 day visit
|
1 day visit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
gene polymorphisms of vitamin D receptor
Time Frame: 1 day visit
|
1 day visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: xiaorong li, Tianjin Medical University Eye Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
August 3, 2015
First Submitted That Met QC Criteria
August 31, 2015
First Posted (Estimate)
September 3, 2015
Study Record Updates
Last Update Posted (Estimate)
April 22, 2016
Last Update Submitted That Met QC Criteria
April 21, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- tjykdxykyy1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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