Fish Oil (Omega 3 ) in Sjogren's Syndrome

Sponsor

Hawler Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05005806

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Sjogren's Syndrome	Drug: Omega 3 fatty acid Drug: Placebo	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 2, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Dry eye symptoms [up to two months]
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
Dry mouth symptoms [up to two months]
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

Secondary Outcome Measures

schirmers tear test [up to two months]
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.
sialometry test [up to two months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Reumatology out patient clinic,	Erbil		Iraq	44001

Sponsors and Collaborators

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