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NCT Number: NCT07255326

Effect of Omega-3 Fatty Acids on Eye Blood Vessels 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.

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Key information

Conditions

Diabetic Retinopathy Autoimmune Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetic Angiopathies Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Omega 3 Fatty Acids Retinal Diseases Type 1 Diabetes Vascular Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Faisalabad

Faisalabad, Punjab Province, 38000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega 3 Fish Oil supplements

Dietary Supplement

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

Other

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.

Primary outcomes

  1. Change in Retinal Artery Diameter

    Time frame: Baseline, 3 Months 6 Months 9 Months

    Change in retinal artery measured using OCTA

  2. Change in Retinal Vein Diameter

    Time frame: Baseline, 3 Months 6 Months 9 Months

    Change in retinal vein diameter measured using OCTA

  3. 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.

  4. 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

Secondary outcomes

  1. Visual Acuity

    Time frame: Baseline, 3 Months 6 Months 9 Months

    Change in VA measured using the logMAR chart at 4 meters

  2. Contrast Sensitivity

    Time frame: Baseline, 3 Months 6 Months 9 Months

    Change in contrast sensitivity measured using the Pelli-Robson chart

  3. 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

Sponsors and collaborators

Lead sponsor

University of Faisalabad

Other

Registry information

Official study title

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

Acronym: O3RETINA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 1, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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