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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-25

Study Completion Date

2023-08-01

Brief Summary

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

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Detailed Description

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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

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Dry Eye Syndromes Celiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention group 1

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

Group Type EXPERIMENTAL

Omega-3 Fatty ACids

Intervention Type DIETARY_SUPPLEMENT

Intervention consists of two different doses of omega-3: high concentration (Intervention group 1) and low concentration (Intervention group 2).

Intervention group 2

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

Group Type EXPERIMENTAL

Omega-3 Fatty ACids

Intervention Type DIETARY_SUPPLEMENT

Intervention consists of two different doses of omega-3: high concentration (Intervention group 1) and low concentration (Intervention group 2).

Control

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

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Supplementation with extra virgin olive oil as a for of positive placebo control.

Interventions

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Omega-3 Fatty ACids

Intervention consists of two different doses of omega-3: high concentration (Intervention group 1) and low concentration (Intervention group 2).

Intervention Type DIETARY_SUPPLEMENT

Control

Supplementation with extra virgin olive oil as a for of positive placebo control.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No