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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 50 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05825976
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Josip Juraj Strossmayer University of Osijek
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Ines Banjari, PhD
Principal Investigator Affiliation Josip Juraj Strossmayer University of Osijek, Faculty of Food Technology, Department of Food and Nutrition Research
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Bosnia and Herzegovina
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Dry Eye Syndromes, Celiac Disease
Additional Details

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).

Arms & Interventions

Arms

Experimental: Intervention group 1

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

Experimental: Intervention group 2

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

Active Comparator: Control

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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Plava Medical Group, Tuzla, Bosnia and Herzegovina

Status

Recruiting

Address

Plava Medical Group

Tuzla, , 75000

Site Contact

Nejra Hodžić, MD

nejrahod88@gmail.com

+38735393111

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