Fish Oil (Omega 3 ) in Sjogren's Syndrome

NCT ID: NCT05005806

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-02
• Study Completion Date: 2023-02-07

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 .

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.

Conditions

Sjogren's Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Omega 3 fatty acid

Intervention Type: DRUG

omega 3 fatty acid soft gel

placebo

placebo group ,placebo soft gel designed same as omega 3 contain Vitamin A 1000 mg twice daily for two months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo soft gel

Interventions

Omega 3 fatty acid

omega 3 fatty acid soft gel

Intervention Type: DRUG

Placebo

placebo soft gel

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hawler Medical University

OTHER

Sponsor Role: lead

Responsible Party

Aryan Mohamadfatih Jalal

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ziad SH AL Rawi, F R C P London

Role: STUDY_DIRECTOR

Professor of Rheumatolgy,Baghdad University

Aryan MF Jalal, M.B.CH.B

Role: PRINCIPAL_INVESTIGATOR

Rheumatology,Hawler medical uiversity,Kurdistan Board for medical specialities

Ibtihal HH Faraj, M-B.CH.B

Role: PRINCIPAL_INVESTIGATOR

Rheumatology,Hawler medical university

Locations

Reumatology out patient clinic,

Erbil, , Iraq

Countries

Iraq

Other Identifiers

Fish oil in Sjogren Syndrome

Identifier Type: -

Identifier Source: org_study_id