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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01793181
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
Anders Kvanta, St. Erik Eye Hospital

Tracking Information
First Submitted Date February 13, 2013
First Posted Date February 15, 2013
Last Update Posted Date November 25, 2016
Study Start Date January 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 13, 2013)
Vitamin D levels [ Time Frame: one year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vitamin D Levels in Patients With Central Retinal Vein Occlusion- a Prospective Controlled Study
Official Title Vitamin 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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood sample of vitamin D
Sampling Method Non-Probability Sample
Study Population Consecutive patients with central retinal vein occlusion diagnosed at St Eriks Eye Hospital
Condition
  • Vitamin d Deficiency
  • Central Retinal Vein Occlusion
Intervention Not Provided
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 23, 2016)
216
Original Estimated Enrollment
 (submitted: February 13, 2013)
240
Actual Study Completion Date November 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Newly diagnosed central retinal vein occlusion (3 months)

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT01793181
Other Study ID Numbers 201149311
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Anders Kvanta, St. Erik Eye Hospital
Study Sponsor St. Erik Eye Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account St. Erik Eye Hospital
Verification Date November 2016