Vitamin D Levels in Patients With Central Retinal Vein Occlusion- a Prospective Controlled Study

ID: NCT01793181
Status: Completed
Phase: N/A
Start Date: January 01, 2013
First Submitted: February 13, 2013
Last Updated: November 23, 2016
Results: N/A
Organization: St. Erik Eye Hospital
Sponsors & Collaborators: St. Erik Eye Hospital
Location: Sweden
Conditions: Vitamin d Deficiency, Central Retinal Vein Occlusion
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Study Description

Brief Summary

Retinal vein occlusion (RVO) is a common vascular disease of the eye. Studies have shown that the risk of venous thrombosis is higher in winter so even concerning RVO. Studies have shown a possible link between sun exposure and venous thrombosis. Vitamin D levels have been shown to have a similar seasonal variation, with a peak occurring in the summer. The primary source of vitamin D is from sunlight when ultraviolet B (UVB) radiation penetrates the skin and converts 7-dehydrocholesterol to 25-hydroxycholecalciferol vitamin D3 (25-OHVitD) via previtamin D. In Stockholm situated at latitude 59˚ 20΄ North, it is not possible to synthesize vitamin D at sufficient levels in winter and the exposure time required to reach a standard dose is impractical from at least October through March.

The aim of the study is to evaluate vitamin D levels in central retinal vein occlusion (CRVO) patients and compare them with the vitamin D levels in randomly selected control patients matched for age and month of disease onset. This is to evaluate whether vitamin D deficiency may be a risk factor in the onset of CRVO.

The hypothesis of the study is that patients with CRVO have lower levels of vitamin d than matched controls.

Detailed Description

The study will last one year and is expected to include 120 patients with RVO and 120 control patients. The first 10 RVO patients visiting St. Erik's Eye Hospital with disease duration of maximum 3 months will be included in the study each month. The control patients will be chosen randomly by the Central Bureau of Statistics and matched for age and gender according to disease distribution known from previous studies. The control group will receive a letter with information of the study, informed consent form and details about the blood sampling procedure. Every month 50 patients in the control group will be invited to participate in the study. Only the first 10 control subjects will be included in the study. Each month a blood sample will be taken from 10 patients with RVO and 10 subjects in the control group. All the subjects will only have one blood sample taken during the study. Blood will be analyzed to measure the vitamin D level. Vitamin D levels will be compared at the end of the study between groups and evaluated according to the time of year for sampling. All the blood sampling will be done by the laboratory at Karolinska University Hospital. Participation in the study is completely voluntary. The details of the study has been reviewed and approved by the Ethics Committee.
Condition or disease Intervention/treatment Phase

Central Retinal Vein Occlusion

Vitamin d Deficiency

N/A

Tracking Information

First Submitted DateFebruary 13, 2013
Last Update Posted DateNovember 23, 2016
Start DateJanuary 01, 2013
Actual Completion DateNovember 01, 2014
Primary Completion DateAugust 01, 2014
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Vitamin D levels [Time Frame: one year]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleVitamin D Levels in Patients With Central Retinal Vein Occlusion- a Prospective Controlled Study
Official TitleVitamin D Levels in Patients With Central Retinal Vein Occlusion- a Prospective Controlled Study
Brief Summary

Retinal vein occlusion (RVO) is a common vascular disease of the eye. Studies have shown that the risk of venous thrombosis is higher in winter so even concerning RVO. Studies have shown a possible link between sun exposure and venous thrombosis. Vitamin D levels have been shown to have a similar seasonal variation, with a peak occurring in the summer. The primary source of vitamin D is from sunlight when ultraviolet B (UVB) radiation penetrates the skin and converts 7-dehydrocholesterol to 25-hydroxycholecalciferol vitamin D3 (25-OHVitD) via previtamin D. In Stockholm situated at latitude 59˚ 20΄ North, it is not possible to synthesize vitamin D at sufficient levels in winter and the exposure time required to reach a standard dose is impractical from at least October through March.

The aim of the study is to evaluate vitamin D levels in central retinal vein occlusion (CRVO) patients and compare them with the vitamin D levels in randomly selected control patients matched for age and month of disease onset. This is to evaluate whether vitamin D deficiency may be a risk factor in the onset of CRVO.

The hypothesis of the study is that patients with CRVO have lower levels of vitamin d than matched controls.

Detailed Description

The study will last one year and is expected to include 120 patients with RVO and 120 control patients. The first 10 RVO patients visiting St. Erik's Eye Hospital with disease duration of maximum 3 months will be included in the study each month. The control patients will be chosen randomly by the Central Bureau of Statistics and matched for age and gender according to disease distribution known from previous studies. The control group will receive a letter with information of the study, informed consent form and details about the blood sampling procedure. Every month 50 patients in the control group will be invited to participate in the study. Only the first 10 control subjects will be included in the study. Each month a blood sample will be taken from 10 patients with RVO and 10 subjects in the control group. All the subjects will only have one blood sample taken during the study. Blood will be analyzed to measure the vitamin D level. Vitamin D levels will be compared at the end of the study between groups and evaluated according to the time of year for sampling. All the blood sampling will be done by the laboratory at Karolinska University Hospital. Participation in the study is completely voluntary. The details of the study has been reviewed and approved by the Ethics Committee.

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
216
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Central Retinal Vein Occlusion
Vitamin d Deficiency
Target Follow-Up Duration N/A
Biospecimen:
Retention: Samples Without DNA
Description: Blood sample of vitamin D
Sampling MethodNon-Probability Sample
Study PopulationConsecutive patients with central retinal vein occlusion diagnosed at St Eriks Eye Hospital
Intervention
Not Available
Study Groups/Cohorts
CRVO patients
Patients with a newly diagnosed CRVO. Maximum duration 3 months.

Control patients
Controls matched for age,gender, month of onset from the Central Bureau of Statistics Sweden

Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Completed
Enrollment216
Completion DateNovember 01, 2014
Eligibility Criteria: Inclusion Criteria:
Newly diagnosed central retinal vein occlusion (3 months)

Exclusion Criteria:
GenderAll
Age50 Years to 90 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Sweden

Administrative Information

NCT Number:NCT01793181
Other Study ID Numbers
201149311
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyAnders Kvanta, St. Erik Eye Hospital
Study Sponsor
St. Erik Eye Hospital
Collaborators
Not Available
Investigators
Not Available