NCT05825976

Omega-3 Fatty Acid Supplementation and Tear Film Quality in Celiac Patients

The Influence of Omega-3 Fatty Acid Supplementation on The Tear Film Quality in Celiac Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Josip Juraj Strossmayer University of Osijek · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Dry Eye Syndromes
• Celiac Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega-3 Fatty ACids	Intervention consists of two different doses of omega-3: high concentration (Intervention group 1) and low concentration (Intervention group 2).
OTHER	Control	Supplementation with extra virgin olive oil as a for of positive placebo control.

Timeline

• Start date: 2023-03-25
• Primary completion: 2023-07-01
• Completion: 2023-08-01
• First posted: 2023-04-24
• Last updated: 2023-04-24

Locations

1 site across 1 country: Bosnia and Herzegovina