Fish Oil (Omega 3 ) in Sjogren's Syndrome

Last updated: February 26, 2024
Sponsor: Hawler Medical University
Overall Status: Completed

Phase

2/3

Condition

Dermatomyositis (Connective Tissue Disease)

Sjogren's Syndrome

Treatment

Omega 3 fatty acid

Placebo

Clinical Study ID

NCT05005806
Fish oil in Sjogren Syndrome
  • Ages 18-70
  • All Genders

Study 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 .

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Omega 3 fatty acid
Phase: 2/3
Study Start date:
September 02, 2021
Estimated Completion Date:
February 07, 2023

Study 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.

Connect with a study center

  • Reumatology out patient clinic,

    Erbil, 44001
    Iraq

    Site Not Available

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