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| ID | Type | Description | Link |
|---|---|---|---|
| TUF/EIRB/253/26 | Other Identifier | The University of Faisalabad |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Change in VA measured using the logMAR chart at 4 meters | Baseline, 3 Months 6 Months 9 Months |
| Contrast Sensitivity | Change in contrast sensitivity measured using the Pelli-Robson chart |
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Type 1 Diabetes with earliest changes i.e. microaneurysms or changes in retinal vessels
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Faisalabad | Faisalabad | Punjab Province | 38000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39966603 | Result | 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. | |
| 37862823 | Result |
| Label | URL |
|---|---|
| Official research portal of The University of Faisalabad, the sponsoring institution for this PhD study. | View source |
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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.
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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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
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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.
| 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. |
|
| Baseline, 3 Months 6 Months 9 Months |
| Blood Sugar Random, Glycosylated hemoglobin (HbA1c), Lipid Profile (Total cholesterol, HDL, LDL, Triglycerides) | 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 |
| 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. |
| The Children's Hospital \& Institute of Child Health, Lahore | View source |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |