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Clinical Trial Summary

The study aims to determine the effectiveness on the tear film quality and symptoms related with dry eye disease in patients with celiac disease.


Clinical Trial Description

Patients diagnosed with celiac disease will be recruited for the study. They will be randomly assigned to one of the three arms (Intervention group 1 - high dose EPA and DHA, Intervention group 2 - low dose EPA and DHA, or Control - extra virgin olive oil) and for 45 days take supplementation as instructed. During the intervention they will be instructed to maintain their diet and lifestyle (i.e. they will not receive any education on diet or lifestyle modification). At inclusion, patients will complete one basic questionnaire on sociodemographic data, one questionnaire which assess accidental exposure to gluten and their weight and height will be measured. Subjective symptoms related to dry eye disease will be assessed with Ocular Surface Disease Index (OSDI) test, while quality and quantity of the tear film will be assessed with the Schirmer's test I and Tear Break-up Time test (TBUT). Dietary intake of omega-3 acids will be controlled by one 24-hour dietary recall (completed at inclusion an after the intervention). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05825976
Study type Interventional
Source Josip Juraj Strossmayer University of Osijek
Contact Nejra Hodžic, MD
Phone +38735393111
Email nejrahod88@gmail.com
Status Recruiting
Phase N/A
Start date March 25, 2023
Completion date August 1, 2023

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