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

Primary Purpose

Dry Eye Syndromes, Celiac Disease

Status
Recruiting
Phase
Not Applicable
Locations
Bosnia and Herzegovina
Study Type
Interventional
Intervention
Omega-3 Fatty ACids
Control
Sponsored by
Josip Juraj Strossmayer University of Osijek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Celiac Disease, Supplementation, Omega-3 Fatty Acids, Dry Eye Syndromes

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Plava Medical GroupRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Intervention group 1

Intervention group 2

Control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
March 28, 2023
Last Updated
April 11, 2023
Sponsor
Josip Juraj Strossmayer University of Osijek
Collaborators
Plava Medical Group, Bosna and Herzegovina
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1. Study Identification

Unique Protocol Identification Number
NCT05825976
Brief Title
Omega-3 Fatty Acid Supplementation and Tear Film Quality in Celiac Patients
Acronym
OmegaCelDED
Official Title
The Influence of Omega-3 Fatty Acid Supplementation on The Tear Film Quality in Celiac Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Josip Juraj Strossmayer University of Osijek
Collaborators
Plava Medical Group, Bosna and Herzegovina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Celiac Disease
Keywords
Celiac Disease, Supplementation, Omega-3 Fatty Acids, Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group 1
Arm Type
Experimental
Arm Description
Supplementation with 2 gel-capsules (each containing 720 mg eicosapentaenoic acid (EPA) and 480 mg docosahexaenoic acid (DHA))
Arm Title
Intervention group 2
Arm Type
Experimental
Arm Description
Supplementation with 2 gel-capsules (each containing 320 mg eicosapentaenoic acid (EPA) and 200 mg docosahexaenoic acid (DHA))
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Supplementation with 2 gel-capsules (each containing 1000 mg extra virgin olive oil)
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 Fatty ACids
Intervention Description
Intervention consists of two different doses of omega-3: high concentration (Intervention group 1) and low concentration (Intervention group 2).
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Supplementation with extra virgin olive oil as a for of positive placebo control.
Primary Outcome Measure Information:
Title
Subjective symptoms of Dry Eye
Description
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.
Time Frame
45 days
Title
Tear Break-up Time
Description
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.
Time Frame
45 days
Title
Schirmer tear test
Description
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
Time Frame
45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nejra Hodžić, MD
Phone
+38735393111
Email
nejrahod88@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ines Banjari, PhD
Organizational Affiliation
Josip Juraj Strossmayer University of Osijek, Faculty of Food Technology, Department of Food and Nutrition Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Plava Medical Group
City
Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nejra Hodžić, MD
Phone
+38735393111
Email
nejrahod88@gmail.com
First Name & Middle Initial & Last Name & Degree
Ines Banjari, PhD
Email
ines.banjari@ptfos.hr
First Name & Middle Initial & Last Name & Degree
Ines Banjari, PhD
First Name & Middle Initial & Last Name & Degree
Nejra Hodžić, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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