Effect of Omega-3 Fatty Acids on Eye Blood Vessels in Type 1 Diabetes (O3RETINA)

June 25, 2026 updated by: Nida Amin, University of Faisalabad

Role of Omega-3 Fatty Acids in Modulating Retinal Microvascular Changes in Type 1 Diabetes

This double-blind, placebo-controlled randomized clinical trial evaluates the effects of omega-3 fatty acid supplementation on retinal vascular structure and function in children and adolescents with type 1 diabetes. The study compares omega-3 supplementation with placebo to assess changes in retinal microvascular parameters, retinal blood flow, visual function, and systemic biomarkers over time, as well as the safety and tolerability of supplementation during the study period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Type 1 diabetes mellitus is associated with early retinal microvascular and hemodynamics alterations that may precede clinically visible diabetic retinopathy. Omega-3 fatty acids have been reported to exert anti-inflammatory, vasoprotective, and neuroprotective effects, and may therefore help preserve retinal vascular integrity and ocular blood flow in individuals with diabetes. This randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the effects of omega-3 supplementation on retinal vascular structure and function in children with type 1 diabetes.

Participants were randomized to receive either omega-3 supplementation or placebo and were followed longitudinally over the study period. Serial ophthalmic and systemic assessments were performed to examine changes in retinal microvascular parameters, retinal blood flow, visual function, and selected systemic biomarkers.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Faisalabad, Punjab Province, Pakistan, 38000
        • The University of Faisalabad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Type 1 Diabetes with earliest changes i.e. microaneurysms or changes in retinal vessels

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omega-3 Group
Participants in this arm received one oral capsule daily containing (1000 mg fish oil containing EPA 180 mg and DHA 120 mg) omega-3 fish oil supplementation for the duration of the study.
Dietary supplement: Omega 3 Fish Oil supplements
Participants received one oral omega-3 fish oil capsule daily for the duration of the study. Each capsule contained 1000 mg fish oil, providing EPA 180 mg and DHA 120 mg.
Placebo Comparator: Placebo Group
Participants in this arm received one oral placebo capsule daily, matched in appearance to the omega-3 supplement but containing no active omega-3 fatty acids, for the duration of the study.
Other: Placebo
Participants received one oral placebo capsule daily, matched in appearance to the omega-3 supplement but containing no active omega-3 fatty acids, for the duration of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Retinal Artery Diameter
Time Frame: Baseline, 3 Months 6 Months 9 Months
Change in retinal artery measured using OCTA
Baseline, 3 Months 6 Months 9 Months
Change in Retinal Vein Diameter
Time Frame: Baseline, 3 Months 6 Months 9 Months
Change in retinal vein diameter measured using OCTA
Baseline, 3 Months 6 Months 9 Months
Change in Foveal Avascular Zone (Area, Perimeter and Circulatory)
Time Frame: Baseline, 3 Months, 6 Months, 9 Months
To measure the change in Foveal Avascular Zone parameter by using OCTA.
Baseline, 3 Months, 6 Months, 9 Months
Central Retinal Artery (PSV, EDV, RI). Central retinal vein (Mean Velocity), Ophthalmic Artery (PSV, EDV, RI), Posterior Ciliary Artery (PSV, EDV, RI)
Time Frame: Baseline, 3 Months, 6 Months, 9 Months
Central Retinal Artery (PSV, EDV, RI). Central retinal vein (Mean Velocity), Ophthalmic Artery (PSV, EDV, RI), Posterior Ciliary Artery (PSV, EDV, RI) blood flow is measured by doppler ultrasound
Baseline, 3 Months, 6 Months, 9 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: Baseline, 3 Months 6 Months 9 Months
Change in VA measured using the logMAR chart at 4 meters
Baseline, 3 Months 6 Months 9 Months
Contrast Sensitivity
Time Frame: Baseline, 3 Months 6 Months 9 Months
Change in contrast sensitivity measured using the Pelli-Robson chart
Baseline, 3 Months 6 Months 9 Months
Blood Sugar Random, Glycosylated hemoglobin (HbA1c), Lipid Profile (Total cholesterol, HDL, LDL, Triglycerides)
Time Frame: Baseline, 3 Months 6 Months 9 Months
Change in Blood Sugar Random, glycosylated hemoglobin (HbA1c), Lipid Profile (Total cholesterol, HDL, LDL, Triglycerides) measured through venous blood sampling
Baseline, 3 Months 6 Months 9 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Faisalabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2025

Primary Completion (Actual)

January 30, 2026

Study Completion (Actual)

February 1, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA_OMEGA3_T1D_RETINA_001
  • TUF/EIRB/253/26 (Other Identifier: The University of Faisalabad)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data will not be shared publicly. Summary-level results will be published in peer-reviewed journals and may be shared with researchers upon reasonable request. Study protocol, statistical analysis plan, and informed consent form may be available upon request from the principal investigator. Researchers can contact the principal investigator for data access requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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