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

Dry Eye Syndromes Clinical Trial

— OmegaCelDED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05825976
• Other study ID #: IBanjari
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: April 2023
• Source: Josip Juraj Strossmayer University of Osijek
• Contact: Nejra Hodžic, MD
• Phone: +38735393111
• Email: nejrahod88[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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.

Locations

Country	Name	City	State
Bosnia and Herzegovina	Plava Medical Group	Tuzla

Sponsors (2)

Lead Sponsor	Collaborator
Josip Juraj Strossmayer University of Osijek	Plava Medical Group, Bosna and Herzegovina

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective symptoms of Dry Eye	Ocular Surface Disease Index or OSID is a 12-item questionnaire which assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Each question is graded on a scale of 0 to 4, where 0 indicates none of the time; 1, some of the time; 2, half of the time; 3, most of the time; and 4, all of the time. The total OSDI score is calculated as OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4]. Total score ranges from 0 to 100 where higher score coresponds with greater disability.	45 days
Primary	Tear Break-up Time	Used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as seen in this progression of these slit lamps photos over time. A TBUT under 10 seconds is considered abnormal.	45 days
Primary	Schirmer tear test	Evaluates aqueous tear production and is helpful in the assessment of patients with signs and/or symptoms of dry eye. Interpretation: normal aqueous tear production is supported by measurements of > 15 mm after 5 minutes, and mild-moderate reduction of aqueous production: 5mm-14mm after 5 minutes	45 days