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

April 11, 2023 updated by: Ines Banjari, Josip Juraj Strossmayer University of Osijek

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group 1
Supplementation with 2 gel-capsules (each containing 720 mg eicosapentaenoic acid (EPA) and 480 mg docosahexaenoic acid (DHA))
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).
Experimental: Intervention group 2
Supplementation with 2 gel-capsules (each containing 320 mg eicosapentaenoic acid (EPA) and 200 mg docosahexaenoic acid (DHA))
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).
Active Comparator: Control
Supplementation with 2 gel-capsules (each containing 1000 mg extra virgin olive oil)
Other: Control
Supplementation with extra virgin olive oil as a for of positive placebo control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective symptoms of Dry Eye
Time Frame: 45 days
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
Tear Break-up Time
Time Frame: 45 days
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
Schirmer tear test
Time Frame: 45 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Josip Juraj Strossmayer University of Osijek

Collaborators

Plava Medical Group, Bosna and Herzegovina

Investigators

  • Principal Investigator: Ines Banjari, PhD, Josip Juraj Strossmayer University of Osijek, Faculty of Food Technology, Department of Food and Nutrition Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2023

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBanjari

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This research is part of PhD project and therefore the results cannot be shared directly. All interested parties can contact investigators after defending the PhD thesis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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