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Trial record 20 of 81 for:    CRVO - Central Retinal Vein Occlusion

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

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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

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
Vitamin d Deficiency Central Retinal Vein Occlusion

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.

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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 : January 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Group/Cohort
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



Primary Outcome Measures :
  1. Vitamin D levels [ Time Frame: one year ]

Biospecimen Retention:   Samples Without DNA
Blood sample of vitamin D


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients with central retinal vein occlusion diagnosed at St Eriks Eye Hospital
Criteria

Inclusion Criteria:

Newly diagnosed central retinal vein occlusion (3 months)

Exclusion Criteria:


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): NCT01793181


Locations
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Sweden
St Eriks Eye Hospital
Stockholm, Sweden, 11282
Sponsors and Collaborators
St. Erik Eye Hospital

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Responsible Party: Anders Kvanta, Associate Professor, St. Erik Eye Hospital
ClinicalTrials.gov Identifier: NCT01793181     History of Changes
Other Study ID Numbers: 201149311
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016

Keywords provided by Anders Kvanta, St. Erik Eye Hospital:
Vitamin d deficiency
Central retinal vein occlusion

Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Venous Thrombosis
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Eye Diseases
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents