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

NCT05825976 | Unknown

• 1 other identifier: IBanjari
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes; Celiac Disease

Keywords

Celiac Disease; Supplementation; Omega-3 Fatty Acids; Dry Eye Syndromes

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  45 days

Study Arms (3)

Intervention group 1

EXPERIMENTAL

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 group 2

EXPERIMENTAL

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

Dietary Supplement: Omega-3 Fatty ACids

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

Omega-3 Fatty ACids DIETARY_SUPPLEMENT

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

Intervention group 1; Intervention group 2

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosis of celiac disease
• signed informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Josip Juraj Strossmayer University of Osijek: lead
• Plava Medical Group, Bosna and Herzegovina: collaborator

Study Sites (1)

Plava Medical Group

Tuzla, 75000, Bosnia and Herzegovina

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes; Celiac Disease

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Ines Banjari, PhD

  Josip Juraj Strossmayer University of Osijek, Faculty of Food Technology, Department of Food and Nutrition Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nejra Hodžić, MD

CONTACT

+38735393111; nejrahod88@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Clinical Nutrition Specialist

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 24, 2023
• Study Start: March 25, 2023
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)