Clinical trial NCT05005806: Fish Oil (Omega 3 ) in Sjogren's Syndrome
Official title: Randomised Double-blind Placebo-controlled Clinical Trial of Fish Oil (Omega 3 ) in Sjögren's Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Sjogren's Syndrome
Keywords: Sjogren's syndrome
Omega 3 fatty acid
dry eye
dry mouth
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dry eye symptoms
timeFrame: up to two months
measure: Dry mouth symptoms
timeFrame: up to two months
Secondary outcomes:
measure: schirmers tear test
timeFrame: up to two months
measure: sialometry test
timeFrame: up to two months
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Reumatology out patient clinic,
Study officials:
affiliation: Professor of Rheumatolgy,Baghdad University
name: Ziad SH AL Rawi, F R C P London
role: STUDY_DIRECTOR
affiliation: Rheumatology,Hawler medical uiversity,Kurdistan Board for medical specialities
name: Aryan MF Jalal, M.B.CH.B
role: PRINCIPAL_INVESTIGATOR
affiliation: Rheumatology,Hawler medical university
name: Ibtihal HH Faraj, M-B.CH.B
role: PRINCIPAL_INVESTIGATOR
References: