Fish Oil (Omega 3 ) in Sjogren's Syndrome

NCT05005806 | Completed Phase 2

• 1 other identifier: Fish oil in Sjogren Syndrome
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 .

Conditions

Sjogren's Syndrome

Keywords

Sjogren's syndrome; Omega 3 fatty acid; dry eye; dry mouth

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• schirmers tear test

  up to two months

• sialometry test

  up to two months

Study Arms (2)

Omega 3 soft gel

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Omega 3 fatty acid DRUG

omega 3 fatty acid soft gel

Omega 3 soft gel

Placebo DRUG

placebo soft gel

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Reumatology out patient clinic,

Erbil, 44001, Iraq

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Dry Eye Syndromes; Xerostomia

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Ziad SH AL Rawi, F R C P London

  Professor of Rheumatolgy,Baghdad University

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 16, 2021
• Study Start: September 2, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 7, 2023
• Last Updated: February 28, 2024

Record last verified: 2022-04

Locations

IR (1)