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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
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.
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.
The University of Faisalabad
Faisalabad, Punjab Province, Pakistan
Change in Retinal Artery Diameter
Change in retinal artery measured using OCTA
Time frame: Baseline, 3 Months 6 Months 9 Months
Change in Retinal Vein Diameter
Change in retinal vein diameter measured using OCTA
Time frame: 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.
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)
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
Time frame: Baseline, 3 Months, 6 Months, 9 Months
Visual Acuity
Change in VA measured using the logMAR chart at 4 meters
Time frame: Baseline, 3 Months 6 Months 9 Months
Contrast Sensitivity
Change in contrast sensitivity measured using the Pelli-Robson chart
Time frame: 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
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Time frame: Baseline, 3 Months 6 Months 9 Months