Vitamin D DeficiencyNCT02539745
Associations of Vitamin D Deficiency and Vitamin D Receptor Polymorphisms With the Risk of Primary Open-angle Glaucoma
An observational study of Vitamin D Deficiency and Primary Open- Angle Glaucoma, run by Lv Yingjuan at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Primary Open- Angle Glaucoma
- What is being tested?
- Vitamin D receptor polymorphic analysis and Serum levels of 1a, 25-Dihydroxyvitamin D3
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary open-angle glaucoma patients and randomly age-matched people as controls in the Han population of Tianjin China
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300384
About this study
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.
- Conditions
- Vitamin D Deficiency, Primary Open- Angle Glaucoma
- Being tested
- Vitamin D receptor polymorphic analysis, Serum levels of 1a, 25-Dihydroxyvitamin D3
- Keywords
- vitamin D, primary open- angle glaucoma
- Medical subject headings
- Vitamin D Deficiency, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D receptor polymorphic analysisOther
Vitamin D receptor polymorphic analysis was studied by real-time polymerase-chain reaction high resolution melting analysis.
Serum levels of 1a, 25-Dihydroxyvitamin D3Other
Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by enzyme-linked immunoabsorbent assay.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Vitamin D receptor polymorphic analysis; Other: Serum levels of 1a, 25-Dihydroxyvitamin D3 | |
| 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. Receives: Other: Vitamin D receptor polymorphic analysis; Other: Serum levels of 1a, 25-Dihydroxyvitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of 1a, 25-Dihydroxyvitamin D3
Measured: 1 day visit
Secondary outcomes (1)
gene polymorphisms of vitamin D receptor
Measured: 1 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startJul 2013
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lv Yingjuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lv Yingjuan, Tianjin Medical University Eye Hospital
- Investigators
- xiaorong li, Study director, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539745
- Sponsor's protocol ID
- tjykdxykyy1
- Status last verified
- Apr 2016
- First submitted
- 3 Aug 2015
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lv Y, Yao Q, Ma W, Liu H, Ji J, Li X. Associations of vitamin D deficiency and vitamin D receptor (Cdx-2, Fok I, Bsm I and Taq I) polymorphisms with the risk of primary open-angle glaucoma. BMC Ophthalmol. 2016 Jul 19;16:116. doi: 10.1186/s12886-016-0289-y.
PubMed 27435453
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations of Vitamin D Deficiency and Vitamin D Receptor Polymorphisms With the Risk of Primary Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT02539745
- Acronym / sponsor ID
- tjykdxykyy1
- Conditions
- Vitamin D Deficiency, Primary Open- Angle Glaucoma
- Keywords
- vitamin D, primary open- angle glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Lv YingjuanUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 3 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary open-angle glaucoma patients | – | Other: Vitamin D receptor polymorphic analysis, Other: Serum levels of 1a, 25-Dihydroxyvitamin D3Serum 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. |
| randomly age-matched people | – | Other: Vitamin D receptor polymorphic analysis, Other: Serum levels of 1a, 25-Dihydroxyvitamin D3Serum 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. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary open-angle glaucoma patients and randomly age-matched people as controls in the Han population of Tianjin China
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D receptor polymorphic analysisVitamin D receptor polymorphic analysis was studied by real-time polymerase-chain reaction high resolution melting analysis. | Other | primary open-angle glaucoma patients, randomly age-matched people |
| Serum levels of 1a, 25-Dihydroxyvitamin D3Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by enzyme-linked immunoabsorbent assay. | Other | primary open-angle glaucoma patients, randomly age-matched people |
Primary outcome
Serum levels of 1a, 25-Dihydroxyvitamin D3
Time frame: 1 day visit
1 secondary outcome
gene polymorphisms of vitamin D receptor
Time frame: 1 day visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- Derived from this study: PubMed 27435453Lv Y, Yao Q, Ma W, Liu H, Ji J, Li X. Associations of vitamin D deficiency and vitamin D receptor (Cdx-2, Fok I, Bsm I and Taq I) polymorphisms with the risk of primary open-angle glaucoma. BMC Ophthalmol. 2016 Jul 19;16:116. doi: 10.1186/s12886-016-0289-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xiaorong li study director
Tianjin Medical University Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Primary Open- Angle Glaucoma, run by Lv Yingjuan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of 1a, 25-Dihydroxyvitamin D3 (time frame: 1 day visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02539745, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2016.