Fish Oil (Omega 3 ) in Sjogren's Syndrome

Hawler Medical University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Sjogren's Syndrome

Treatments: Drug: Omega 3 fatty acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05005806

Fish oil in Sjogren Syndrome

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Omega 3 soft gel

Active Comparator group

Description:

participants in this group (1)omega 3 fatty acid soft gel 1000 mg will be given to participants twice daily for two months.

Treatment:

Drug: Omega 3 fatty acid

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo