Fish Oil (Omega 3 ) in Sjogren's Syndrome

• ClinicalTrials.gov Identifier: NCT05005806
• Recruitment Status: Recruiting
• First Posted: August 16, 2021
• Last Update Posted: April 26, 2022
• Sponsor: Hawler Medical University
• Information provided by (Responsible Party): Aryan Mohamadfatih Jalal, Hawler Medical University

Study Description

Brief Summary:

Sjögren's syndrome (pSS) is an autoimmune disorder affecting mainly the exocrine glands.this lead to dryness of the main mucosal surface ,such as the mouth ,eye,skin nose,pharynx,larynx and vagina . The history of the disease is characterized by a slowly progression of sicca symptoms and fatigue; however, a subset of patients would experience extra glandular activity. Lipid mediators derived from polyunsaturated fatty acids, related to inflammation and immune response regulation. In this sense, the polyunsaturated fatty acids omega-3 (ω-3 FA) have been associated with several illnesses such as cancer, cardiovascular disease and autoimmune diseases and their balance at the cellular membranes can result in an anti-inflammatory .

Condition or disease	Intervention/treatment	Phase
Sjogren's Syndrome	Drug: Omega 3 fatty acid; Drug: Placebo	Phase 2; Phase 3

Detailed Description:

this is a randomized double -blind placebo -controlled clinical trial .the participants will be randomize into two groups .Group 1 receive dietary omega-3 supplementation (omega-3 group) whereas Group 2(placebo group) receive a placebo . The two types are similar to each other in the form of soft gel ,both are given two times daily for two months with follow-up of patients whom they full fill the inclusion criteria.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 100 participants will asses for eligibility and underwent randomized double blind placebo controlled clinical trial .in whom they meet inclusion criteria with informed consent from participants and will be held at out patient clinic of Rheumatology department at Erbil- Iraq.
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomised Double-blind Placebo-controlled Clinical Trial of Fish Oil (Omega 3 ) in Sjögren's Syndrome Patients
• Actual Study Start Date: September 2, 2021
• Estimated Primary Completion Date: August 2022
• Estimated Study Completion Date: September 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Omega 3 soft gel; participants in this group (1)omega 3 fatty acid soft gel 1000 mg will be given to participants twice daily for two months.	Drug: Omega 3 fatty acid; omega 3 fatty acid soft gel
Placebo Comparator: placebo; placebo group ,placebo soft gel designed same as omega 3 contain Vitamin A 1000 mg twice daily for two months	Drug: Placebo; placebo soft gel

Outcome Measures

Primary Outcome Measures :

1. Dry eye symptoms [ Time Frame: up to two months ]
   subjective symptoms of dry eye which involve 6 symptoms( burning sensation, itching, foreign body sensation , Dryness, mucous discharge, photophobia) when absent(0) , sometime present (1) , frequently present (2), always present (3) ( score 0-6 mild, 6-12 moderate, 12-18 sever by visual analogue scale
2. Dry mouth symptoms [ Time Frame: up to two months ]
   measure dry mouth by inventory xerostomia score is included 11 questionnaire which score calculated by visual analogue scale from 1 to 5 ( never to very often ) have symptoms

Secondary Outcome Measures :

1. schirmers tear test [ Time Frame: up to two months ]
   patient will sitt in examining chair ,the test strip is bend with round wick and at indentation ( approximately 90 degree ) then patient instruct to look up and draw eye gently downward ,then round bend end of sterile strip hook over eyelid border at junction of middle and outer one third of the lower eyelid margin.
2. sialometry test [ Time Frame: up to two months ]
   measuring of salivary flow ,unstimulated whole saliva is collect when mouth rinse with distill water then the patient tow his head and try not to move during the test, a plastic disposable pipette drew the accumulated saliva in the floor of the mouth,for a period of five minute,the volume will record ,flow express as ml/min.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age≥ 18 and ≤ 70 years old .
• Able to provide inform consent
• Patients diagnosed as syndrome according to 2016 ACR(American college of Rheumatology)/ EULAR(European league Against Rheumatism classification criteria for Sjögren's syndrome

Exclusion Criteria:

• any preexisting ocular disease or on eye drops lubricants.
• patients on (Beta blockers, Diuretics , anticholinergic, α 1antagonist and α 2 agonist ,anticoagulant, antidepressant, antihistamine ,pilocarpine, cevimeline ) .
• past history of diabetes, psychiatric disorder.
• pregnancy, lactating mother
• malignancy

Contacts and Locations

Contacts

Contact: Aryan MF Jalal, M.B.CH.B; 009647504880817; aryan.jalal87@yahoo.com

Contact: Ibtihal HH Faraj, M.B.CH.B; 009647507584463; Ibtihal.hikmet@yahoo.com

Locations

Iraq

Reumatology out patient clinic,; Recruiting

Erbil, Iraq, 44001

Sponsors and Collaborators

Hawler Medical University

Investigators

• Study Director: Ziad SH AL Rawi, F R C P London; Professor of Rheumatolgy,Baghdad University
• Principal Investigator: Aryan MF Jalal, M.B.CH.B; Rheumatology,Hawler medical uiversity,Kurdistan Board for medical specialities
• Principal Investigator: Ibtihal HH Faraj, M-B.CH.B; Rheumatology,Hawler medical university

More Information

• Responsible Party: Aryan Mohamadfatih Jalal, principal investigator, Hawler Medical University
• ClinicalTrials.gov Identifier: NCT05005806
• Other Study ID Numbers: Fish oil in Sjogren Syndrome
• First Posted: August 16, 2021
• Last Update Posted: April 26, 2022
• Last Verified: April 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aryan Mohamadfatih Jalal, Hawler Medical University:

Sjogren's syndrome; Omega 3 fatty acid; dry eye; dry mouth

Additional relevant MeSH terms:

Sjogren's Syndrome; Syndrome; Disease; Pathologic Processes; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases