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

NCT07255326 | Completed DMC

• 2 other identifiers: NIDA_OMEGA3_T1D_RETINA_001TUF/EIRB/253/26
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Retinopathy; Type 1 Diabetes; Omega 3 Fatty Acids

Keywords

Diabetic retinopathy; retinal microvasculature; type 1 diabetes; retinal blood flow

Outcome Measures

Primary Outcomes (4)

• Change in Retinal Artery Diameter

  Change in retinal artery measured using OCTA

  Baseline, 3 Months 6 Months 9 Months

• Change in Retinal Vein Diameter

  Change in retinal vein diameter measured using OCTA

  Baseline, 3 Months 6 Months 9 Months

• Change in Foveal Avascular Zone (Area, Perimeter and Circulatory)

  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)

  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 Outcomes (3)

• Visual Acuity

  Baseline, 3 Months 6 Months 9 Months

• Contrast Sensitivity

  Baseline, 3 Months 6 Months 9 Months

• Blood Sugar Random, Glycosylated hemoglobin (HbA1c), Lipid Profile (Total cholesterol, HDL, LDL, Triglycerides)

  Baseline, 3 Months 6 Months 9 Months

Study Arms (2)

Omega-3 Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

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.

Omega-3 Group

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.

Placebo Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Faisalabad: lead

Study Sites (1)

The University of Faisalabad

Faisalabad, Punjab Province, 38000, Pakistan

Location

Related Publications (2)

• Sala-Vila A, Vinagre I, Cofan M, Lazaro I, Ale-Chilet A, Barraso M, Hernandez T, Harris WS, Zarranz-Ventura J, Ortega E. Blood omega-3 biomarkers, diabetic retinopathy and retinal vessel status in patients with type 1 diabetes. Eye (Lond). 2025 Jun;39(8):1526-1531. doi: 10.1038/s41433-025-03705-5. Epub 2025 Feb 18.

  PMID: 39966603 RESULT

• Elbarbary NS, Ismail EAR, Mohamed SA. Omega-3 fatty acids supplementation improves early-stage diabetic nephropathy and subclinical atherosclerosis in pediatric patients with type 1 diabetes: A randomized controlled trial. Clin Nutr. 2023 Dec;42(12):2372-2380. doi: 10.1016/j.clnu.2023.10.007. Epub 2023 Oct 13.

  PMID: 37862823 RESULT

Related Links

• Official research portal of The University of Faisalabad, the sponsoring institution for this PhD study.
• The Children's Hospital \& Institute of Child Health, Lahore

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This was a double-blind, placebo-controlled randomized clinical trial. Participants, care providers, investigators, and outcome assessors were blinded to treatment allocation throughout the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor/HOD Optometry Department

Model Details: Participants will be randomly assigned to either the omega-3 group or a placebo group. Both groups will attend regular eye exams every three months to monitor changes in retinal blood vessels. Outcomes will be compared between the two groups to assess the effects of omega-3 supplementation

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 1, 2025
• Study Start: February 12, 2025
• Primary Completion: January 30, 2026
• Study Completion: February 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

PA (1)