Dry Eye SyndromesOmegaCelDEDNCT05825976
Omega-3 Fatty Acid Supplementation and Tear Film Quality in Celiac Patients
A study testing Omega-3 Fatty ACids in people with Dry Eye Syndromes and Celiac Disease, run by Josip Juraj Strossmayer University of Osijek at 1 site in Bosnia and Herzegovina.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dry Eye Syndromes, Celiac Disease
- What is being tested?
- Omega-3 Fatty ACids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBosnia and Herzegovina
- Study dates
- 25 Mar 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of celiac disease
- signed informed consent form
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
Bosnia and Herzegovina1 site, 1 recruiting
- Recruiting
Plava Medical Group
Tuzla, 75000
Nejra Hodžić, MD, +38735393111, nejrahod88@gmail.com
Ines Banjari, PhD, ines.banjari@ptfos.hr
About this study
Official title: 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.
Read the 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).
- Conditions
- Dry Eye Syndromes, Celiac Disease
- Being tested
- Omega-3 Fatty ACids, Control
- Keywords
- Celiac Disease, Supplementation, Omega-3 Fatty Acids, Dry Eye Syndromes
- Medical subject headings
- Dry Eye Syndromes, Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty ACidsDietary supplement
Intervention consists of two different doses of omega-3: high concentration (Intervention group 1) and low concentration (Intervention group 2).
ControlOther
Supplementation with extra virgin olive oil as a for of positive placebo control.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group 1 | Experimental | Supplementation with 2 gel-capsules (each containing 720 mg eicosapentaenoic acid (EPA) and 480 mg docosahexaenoic acid (DHA)) Receives: Dietary Supplement: Omega-3 Fatty ACids |
| Intervention group 2 | Experimental | Supplementation with 2 gel-capsules (each containing 320 mg eicosapentaenoic acid (EPA) and 200 mg docosahexaenoic acid (DHA)) Receives: Dietary Supplement: Omega-3 Fatty ACids |
| Control | Active comparator | Supplementation with 2 gel-capsules (each containing 1000 mg extra virgin olive oil) Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 45 days
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.
Measured: 45 days
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
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start25 Mar 2023
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Collaborators
- Plava Medical Group, Bosna and Herzegovina
- Responsible party
- Principal investigator, Ines Banjari, Josip Juraj Strossmayer University of Osijek
- Investigators
- Ines Banjari, PhD, Principal investigator, Josip Juraj Strossmayer University of Osijek, Faculty of Food Technology, Department of Food and Nutrition Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825976
- Sponsor's protocol ID
- IBanjari
- Acronym
- OmegaCelDED
- Status last verified
- Apr 2023
- First submitted
- 28 Mar 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Omega-3 Fatty Acid Supplementation on The Tear Film Quality in Celiac Patients
- ClinicalTrials.gov ID
- NCT05825976
- Acronym / sponsor ID
- OmegaCelDED / IBanjari
- Conditions
- Dry Eye Syndromes, Celiac Disease
- Keywords
- Celiac Disease, Supplementation, Omega-3 Fatty Acids, Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Collaborators
- Plava Medical Group, Bosna and Herzegovina
- Study start
- 25 Mar 2023 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group 1 | Experimental | Dietary Supplement: Omega-3 Fatty ACidsSupplementation with 2 gel-capsules (each containing 720 mg eicosapentaenoic acid (EPA) and 480 mg docosahexaenoic acid (DHA)) |
| Intervention group 2 | Experimental | Dietary Supplement: Omega-3 Fatty ACidsSupplementation with 2 gel-capsules (each containing 320 mg eicosapentaenoic acid (EPA) and 200 mg docosahexaenoic acid (DHA)) |
| Control | Active comparator | Other: ControlSupplementation with 2 gel-capsules (each containing 1000 mg extra virgin olive oil) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- diagnosis of celiac disease
- signed informed consent form
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Fatty ACidsIntervention consists of two different doses of omega-3: high concentration (Intervention group 1) and low concentration (Intervention group 2). | Dietary supplement | Intervention group 1, Intervention group 2 |
| ControlSupplementation with extra virgin olive oil as a for of positive placebo control. | Other | Control |
Primary outcome
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.
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ines Banjari, PhD principal investigator
Josip Juraj Strossmayer University of Osijek, Faculty of Food Technology, Department of Food and Nutrition Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fatty ACids in people with Dry Eye Syndromes and Celiac Disease, run by Josip Juraj Strossmayer University of Osijek at 1 site in Bosnia and Herzegovina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nejra Hodžić, MD (+38735393111, nejrahod88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective symptoms of Dry Eye (time frame: 45 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.