NCT05005806

Fish Oil (Omega 3 ) in Sjogren's Syndrome

Randomised Double-blind Placebo-controlled Clinical Trial of Fish Oil (Omega 3 ) in Sjögren's Syndrome Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Hawler Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Omega 3 fatty acid	omega 3 fatty acid soft gel
DRUG	Placebo	placebo soft gel

Timeline

• Start date: 2021-09-02
• Primary completion: 2023-02-01
• Completion: 2023-02-07
• First posted: 2021-08-16
• Last updated: 2024-02-28

Locations

1 site across 1 country: Iraq