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

Last updated: April 11, 2023
Sponsor: Josip Juraj Strossmayer University of Osijek
Overall Status: Active - Recruiting

Phase

N/A

Condition

Celiac Disease

Sjogren's Syndrome

Eyelid Inflammation

Treatment

N/A

Clinical Study ID

NCT05825976
IBanjari
  • Ages 18-50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • diagnosis of celiac disease
  • signed informed consent form

Exclusion

Exclusion Criteria:

  • use of medications for diabetes, hypertension, depression, thyroid disease, allergies,epilepsy, psychosis, glaucoma
  • use of oral contraceptive pills
  • alcoholism or use of alcohol on the day of recruitment
  • menopause
  • eye trauma or surgery in the past 3 months
  • wearing contact lens
  • supplementation with omega-3 fatty acids regardless of the dose used in the past month
  • not understanding Bosnian letter or language
  • Informed consent form not signed

Study Design

Total Participants: 45
Study Start date:
March 25, 2023
Estimated Completion Date:
August 01, 2023

Study 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).

Connect with a study center

  • Plava Medical Group

    Tuzla, 75000
    Bosnia and Herzegovina

    Active - Recruiting

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