Fish Oil (Omega 3 ) in Sjogren's Syndrome

Sjogren's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05005806
• Other study ID #: Fish oil in Sjogren Syndrome
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2, 2021
• Est. completion date: February 7, 2023

Study information

• Verified date: April 2022
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 7, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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, a 1antagonist and a 2 agonist ,anticoagulant, antidepressant, antihistamine ,pilocarpine, cevimeline ) .

• past history of diabetes, psychiatric disorder.

• pregnancy, lactating mother

• malignancy

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• Omega 3 fatty acid
omega 3 fatty acid soft gel
• Placebo
placebo soft gel

Locations

Country	Name	City	State
Iraq	Reumatology out patient clinic,	Erbil

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dry eye symptoms	subjective symptoms of dry eye which involve 6 symptoms( burning sensation, itching, foreign body sensation , Dryness, mucous discharge, photophobia) when absent(0) , sometime present (1) , frequently present (2), always present (3) ( score 0-6 mild, 6-12 moderate, 12-18 sever by visual analogue scale	up to two months
Primary	Dry mouth symptoms	measure dry mouth by inventory xerostomia score is included 11 questionnaire which score calculated by visual analogue scale from 1 to 5 ( never to very often ) have symptoms	up to two months
Secondary	schirmers tear test	patient will sitt in examining chair ,the test strip is bend with round wick and at indentation ( approximately 90 degree ) then patient instruct to look up and draw eye gently downward ,then round bend end of sterile strip hook over eyelid border at junction of middle and outer one third of the lower eyelid margin.	up to two months
Secondary	sialometry test	measuring of salivary flow ,unstimulated whole saliva is collect when mouth rinse with distill water then the patient tow his head and try not to move during the test, a plastic disposable pipette drew the accumulated saliva in the floor of the mouth,for a period of five minute,the volume will record ,flow express as ml/min.	up to two months