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

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 .

Study Overview

• Status: Completed
• Conditions: Sjogren's Syndrome
• Intervention / Treatment: Drug: Omega 3 fatty acid; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Aryan MF Jalal, M.B.CH.B; Phone Number: 009647504880817; Email: aryan.jalal87@yahoo.com
• Study Contact Backup: Name: Ibtihal HH Faraj, M.B.CH.B; Phone Number: 009647507584463; Email: Ibtihal.hikmet@yahoo.com

Study Locations

• Iraq
  • Erbil, Iraq, 44001
    • Reumatology out patient clinic,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Omega 3 soft gel; participants in this group (1)omega 3 fatty acid soft gel 1000 mg will be given to participants twice daily for two months.	Drug: Omega 3 fatty acid; omega 3 fatty acid soft gel
Placebo Comparator: placebo; placebo group ,placebo soft gel designed same as omega 3 contain Vitamin A 1000 mg twice daily for two months	Drug: Placebo; placebo soft gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hawler Medical University
• Investigators: Study Director: Ziad SH AL Rawi, F R C P London, Professor of Rheumatolgy,Baghdad University; Principal Investigator: Aryan MF Jalal, M.B.CH.B, Rheumatology,Hawler medical uiversity,Kurdistan Board for medical specialities; Principal Investigator: Ibtihal HH Faraj, M-B.CH.B, Rheumatology,Hawler medical university

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 7, 2023

Study Registration Dates

• First Submitted: August 5, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: dry eye; Sjogren's syndrome; dry mouth; Omega 3 fatty acid
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: Fish oil in Sjogren Syndrome

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No