Associations of Vitamin D Deficiency and Vitamin D Receptor Polymorphisms With the Risk of Primary Open-angle Glaucoma

Vitamin D Deficiency Clinical Trial

Official title:

Associations of Vitamin D Deficiency and Vitamin D Receptor Polymorphisms With the Risk of Primary Open-angle Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539745
• Other study ID #: tjykdxykyy1
• Status: Completed
• Phase: N/A
• First received: August 3, 2015
• Last updated: August 31, 2015
• Start date: July 2013
• Est. completion date: March 2015

Study information

• Verified date: August 2015
• Source: Tianjin Medical University Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Tianjin Municipal Health Bureau
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open- Angle Glaucoma
• Vitamin D Deficiency

Intervention

Other:
• Vitamin D receptor polymorphic analysis
Vitamin D receptor polymorphic analysis was studied by real-time polymerase-chain reaction high resolution melting analysis.
• Serum levels of 1a, 25-Dihydroxyvitamin D3
Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by enzyme-linked immunoabsorbent assay.

Locations

Country	Name	City	State
China	Tianjin Medical University Eye Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Lv Yingjuan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum levels of 1a, 25-Dihydroxyvitamin D3		1 day visit	No
Secondary	gene polymorphisms of vitamin D receptor		1 day visit	No