NCT01793181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

1.6 years

First QC Date

February 13, 2013

Last Update Submit

November 23, 2016

Conditions

Keywords

Vitamin d deficiencyCentral retinal vein occlusion

Outcome Measures

Primary Outcomes (1)

  • Vitamin D levels

    one year

Study Arms (2)

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

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients with central retinal vein occlusion diagnosed at St Eriks Eye Hospital

You may qualify if:

  • Newly diagnosed central retinal vein occlusion (3 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Eriks Eye Hospital

Stockholm, Stockholm County, 11282, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample of vitamin D

MeSH Terms

Conditions

Vitamin D DeficiencyRetinal Vein Occlusion

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesRetinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 15, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2014

Study Completion

November 1, 2014

Last Updated

November 25, 2016

Record last verified: 2016-11

Locations