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

Sponsor
St. Erik Eye Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01793181
Collaborator
(none)
216
1
22
9.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    216 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Vitamin D Levels in Patients With Central Retinal Vein Occlusion- a Prospective Controlled Study
    Study Start Date :
    Jan 1, 2013
    Actual Primary Completion Date :
    Aug 1, 2014
    Actual Study Completion Date :
    Nov 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Vitamin D levels [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Newly diagnosed central retinal vein occlusion (3 months)

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Eriks Eye Hospital Stockholm Sweden 11282

    Sponsors and Collaborators

    • St. Erik Eye Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anders Kvanta, Associate Professor, St. Erik Eye Hospital
    ClinicalTrials.gov Identifier:
    NCT01793181
    Other Study ID Numbers:
    • 201149311
    First Posted:
    Feb 15, 2013
    Last Update Posted:
    Nov 25, 2016
    Last Verified:
    Nov 1, 2016
    Keywords provided by Anders Kvanta, Associate Professor, St. Erik Eye Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 25, 2016