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

April 27, 2026 updated by: Nida Amin, University of Faisalabad

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

The aim of this clinical trial is to learn if omega-3 fatty acid supplements help maintain healthy blood vessels in the eyes of adults with type 1 diabetes. It will also learn about the safety of omega-3 supplements. The main questions it aims to answer are:

Do omega-3 supplements improve the health of retinal blood vessels in adults with type 1 diabetes? Are there any side effects when taking omega-3 supplements? Researchers will compare participants taking omega-3 supplements to a control group (if applicable) to see if the supplements help support retinal blood vessel health.

Participants will:

Take a daily omega-3 supplement for the duration of the study Attend regular eye exams to monitor changes in the retina Report any side effects or health changes during the study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

People with type 1 diabetes are at risk of having changes in microvasculature of the retina, which may impair visual functions with time. This paper examines the potential of daily supplemental intake of omega -3 fatty acids to maintain retinal vascularity and prevent the ocular complications linked to diabetes. The researchers seek to know whether the supplements can protect the eyes and enhance the long-term eye health.

The trial participants will consume a daily dose of omega 3 and visit a clinic after every quarterly interval to take ophthalmic tests. In the process of such appointments the research team will examine the health of the retinal and record any vascular changes. Another questionnaire that will be administered to the participants is the one that focuses on adverse events, including mild gastrointestinal discomfort, linked to supplementation.

The trial period will take around 12 months. The control cohort will be assigned to the non-supplemented group in order to compare the differences in retinal microvascular health in subjects subjected to omega-3 supplementation. The results although may not have immediate therapeutic value would inform future interventions to prevent or mitigate ocular complications in people with type 1 diabetes.

Study Type

Interventional

Enrollment (Actual)

82

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
      • Lahore, Punjab Province, Pakistan, 54000
        • Children Hospital Lahore and Ali Fatima Hospital

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 Supplement Group
Participants will take one daily capsule containing 1000 mg of combined EPA and DHA. The supplement is taken orally with food. Eye exams will be performed every three months to monitor retinal blood vessel health.
Dietary supplement: Omega 3 Fish Oil supplements

Arm 1 - Omega-3 Supplement Group:

Intervention Type: Dietary Supplement Intervention Name: Omega-3 Fatty Acid Supplement

Intervention Description:

Participants will take one daily capsule containing 1000 mg of combined EPA and DHA. The supplement is taken orally with food. Eye exams will be performed every three months to monitor retinal blood vessel health. Participants will report any side effects such as mild stomach upset.

Arm 2 - Placebo / Control Group:

Intervention Type: Placebo Intervention Name: Placebo Capsule

Intervention Description:

Participants will take a daily capsule that looks identical to the omega-3 supplement but contains no active omega-3 fatty acids. Eye exams will be performed every three months to monitor retinal blood vessel health. Participants will report any health changes.

Other Names:
  • Placebo
Placebo Comparator: Omega-3 Control Group
Participants will take a daily capsule that looks identical to the omega-3 supplement but contains no active omega-3 fatty acids. Eye exams will be performed every three months to monitor retinal blood vessel health. Participants will report any health changes.
Dietary supplement: Omega 3 Fish Oil supplements

Arm 1 - Omega-3 Supplement Group:

Intervention Type: Dietary Supplement Intervention Name: Omega-3 Fatty Acid Supplement

Intervention Description:

Participants will take one daily capsule containing 1000 mg of combined EPA and DHA. The supplement is taken orally with food. Eye exams will be performed every three months to monitor retinal blood vessel health. Participants will report any side effects such as mild stomach upset.

Arm 2 - Placebo / Control Group:

Intervention Type: Placebo Intervention Name: Placebo Capsule

Intervention Description:

Participants will take a daily capsule that looks identical to the omega-3 supplement but contains no active omega-3 fatty acids. Eye exams will be performed every three months to monitor retinal blood vessel health. Participants will report any health changes.

Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Retinal Artery Diameter
Time Frame: 3 Months 6 Months 9 Months
Change in central retinal artery equivalent measured from fundus photographs using OCTA
3 Months 6 Months 9 Months
Change in Retinal Vein Diameter
Time Frame: 3 Months 6 Months 9 Months
Change in central retinal vein equivalent measured from fundus photographs using OCTA
3 Months 6 Months 9 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Best-Corrected Visual Acuity
Time Frame: 3 Months 6 Months 9 Months
Change in BCVA measured using the logMAR chart at 4 meters
3 Months 6 Months 9 Months
Change in Contrast Sensitivity
Time Frame: 3 Months 6 Months 9 Months
Change in contrast sensitivity measured using the Pelli-Robson chart
3 Months 6 Months 9 Months
Change in HbA1c
Time Frame: 3 Months 6 Months 9 Months
Change in glycosylated hemoglobin (HbA1c) measured through laboratory blood testing
3 Months 6 Months 9 Months
Change in Fasting Blood Glucose
Time Frame: 3 Months 6 Months 9 Months
Change in Random blood Sugar measured through venous blood sampling
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)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA_OMEGA3_T1D_RETINA_001
  • 1174/CH-UCHS (Other Identifier: The Children's Hospital & University of Child Health Sciences, Lahore)

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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