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

Josip Juraj Strossmayer University of Osijek

Status: Enrolling

Conditions: Celiac Disease; Dry Eye Syndromes

Treatments: Other: Control; Dietary Supplement: Omega-3 Fatty ACids

Study type: Interventional

Funder types: Other

Identifiers

NCT05825976

IBanjari

Details and patient eligibility

About

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

Full 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).

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of celiac disease
• signed informed consent form

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

45 participants in 3 patient groups

Intervention group 1

Experimental group

Description:

Supplementation with 2 gel-capsules (each containing 720 mg eicosapentaenoic acid (EPA) and 480 mg docosahexaenoic acid (DHA))

Treatment:

Dietary Supplement: Omega-3 Fatty ACids

Intervention group 2

Experimental group

Description:

Supplementation with 2 gel-capsules (each containing 320 mg eicosapentaenoic acid (EPA) and 200 mg docosahexaenoic acid (DHA))

Treatment:

Dietary Supplement: Omega-3 Fatty ACids

Control

Active Comparator group

Description:

Supplementation with 2 gel-capsules (each containing 1000 mg extra virgin olive oil)

Treatment:

Other: Control