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

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ClinicalTrials.gov Identifier: NCT02539745
Recruitment Status : Completed
First Posted : September 3, 2015
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
Lv Yingjuan, Tianjin Medical University Eye Hospital

Brief 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.

Condition or disease Intervention/treatment
Vitamin D Deficiency Primary Open- Angle Glaucoma Other: Vitamin D receptor polymorphic analysis Other: Serum levels of 1a, 25-Dihydroxyvitamin D3

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Associations of Vitamin D Deficiency and Vitamin D Receptor Polymorphisms With the Risk of Primary Open-angle Glaucoma
Study Start Date : July 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015


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.
Other: Vitamin D receptor polymorphic analysis
Vitamin D receptor polymorphic analysis was studied by real-time polymerase-chain reaction high resolution melting analysis.

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

Other: Serum levels of 1a, 25-Dihydroxyvitamin D3
Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by enzyme-linked immunoabsorbent assay.




Primary Outcome Measures :
  1. Serum levels of 1a, 25-Dihydroxyvitamin D3 [ Time Frame: 1 day visit ]

Secondary Outcome Measures :
  1. gene polymorphisms of vitamin D receptor [ Time Frame: 1 day visit ]

Biospecimen Retention:   Samples With DNA
Cdx-2, Fok I, Bsm I and Taq I polymorphisms


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Ages Eligible for Study:   55 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539745


Locations
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China, Tianjin
Tianjin Medical University Eye Hospital
Tianjin, Tianjin, China, 300384
Sponsors and Collaborators
Lv Yingjuan
Investigators
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Study Director: xiaorong li Tianjin Medical University Eye Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lv Yingjuan, department of ophthamology, Tianjin Medical University Eye Hospital
ClinicalTrials.gov Identifier: NCT02539745     History of Changes
Other Study ID Numbers: tjykdxykyy1
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Keywords provided by Lv Yingjuan, Tianjin Medical University Eye Hospital:
vitamin D
primary open- angle glaucoma
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Vitamin D Deficiency
Ocular Hypertension
Eye Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Dihydroxycholecalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents