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

NCT07255326 | Completed DMC

• 2 other identifiers: NIDA_OMEGA3_T1D_RETINA_0011174/CH-UCHS
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Retinopathy; Type 1 Diabetes; Omega 3 Fatty Acids

Keywords

Diabetic retinopathy; retinal microvasculature; omega 3 fatty acids; type 1 diabetes

Outcome Measures

Primary Outcomes (2)

• Change in Retinal Artery Diameter

  Change in central retinal artery equivalent measured from fundus photographs using OCTA

  3 Months 6 Months 9 Months

• Change in Retinal Vein Diameter

  Change in central retinal vein equivalent measured from fundus photographs using OCTA

  3 Months 6 Months 9 Months

Secondary Outcomes (4)

• Change in Best-Corrected Visual Acuity

  3 Months 6 Months 9 Months

• Change in Contrast Sensitivity

  3 Months 6 Months 9 Months

• Change in HbA1c

  3 Months 6 Months 9 Months

• Change in Fasting Blood Glucose

  3 Months 6 Months 9 Months

Study Arms (2)

Omega-3 Supplement Group

EXPERIMENTAL

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

Omega-3 Control Group

PLACEBO COMPARATOR

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

Interventions

Omega 3 Fish Oil supplements DIETARY_SUPPLEMENT

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.

Also known as: Placebo

Omega-3 Control Group; Omega-3 Supplement 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)

Children Hospital Lahore and Ali Fatima Hospital

Lahore, Punjab Province, 54000, 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: Laboratory staff analyzing blood samples and retinal imaging technicians will be blinded to group assignments
• 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 supplement group or a control group that does not receive the supplement. 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: May 1, 2026

Record last verified: 2026-04

Locations

PA (1)