Diabetic RetinopathyO3RETINANCT07255326
Effect of Omega-3 Fatty Acids on Eye Blood Vessels in Type 1 Diabetes
A study testing Omega 3 Fish Oil supplements in people with Diabetic Retinopathy and Type 1 Diabetes, run by University of Faisalabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Diabetic Retinopathy, Type 1 Diabetes, Omega 3 Fatty Acids
- What is being tested?
- Omega 3 Fish Oil supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Feb 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Type 1 Diabetes with earliest changes i.e. microaneurysms or changes in retinal vessels
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The University of Faisalabad
Faisalabad, Punjab Province, 38000
About this study
Official title: Role of Omega-3 Fatty Acids in Modulating Retinal Microvascular Changes 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.
Read the detailed description
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.
- Conditions
- Diabetic Retinopathy, Type 1 Diabetes, Omega 3 Fatty Acids
- Being tested
- Omega 3 Fish Oil supplements, Placebo
- Keywords
- Diabetic retinopathy, retinal microvasculature, type 1 diabetes, retinal blood flow
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 Fish Oil supplementsDietary 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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Retinal Artery Diameter
Change in retinal artery measured using OCTA
Measured: Baseline, 3 Months 6 Months 9 Months
Change in Retinal Vein Diameter
Change in retinal vein diameter measured using OCTA
Measured: 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.
Measured: 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
Measured: Baseline, 3 Months, 6 Months, 9 Months
Secondary outcomes (3)
Visual Acuity
Change in VA measured using the logMAR chart at 4 meters
Measured: Baseline, 3 Months 6 Months 9 Months
Contrast Sensitivity
Change in contrast sensitivity measured using the Pelli-Robson chart
Measured: 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
Measured: Baseline, 3 Months 6 Months 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start12 Feb 2025
- Primary completion30 Jan 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nida Amin, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255326
- Sponsor's protocol ID
- NIDA_OMEGA3_T1D_RETINA_001
- Other IDs
- TUF/EIRB/253/26
- Acronym
- O3RETINA
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 39966603Elbarbary 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.
PubMed 37862823
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Omega-3 Fatty Acids in Modulating Retinal Microvascular Changes in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07255326
- Acronym / sponsor ID
- O3RETINA / NIDA_OMEGA3_T1D_RETINA_001
- Conditions
- Diabetic Retinopathy, Type 1 Diabetes, Omega 3 Fatty Acids
- Keywords
- Diabetic retinopathy, retinal microvasculature, type 1 diabetes, retinal blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Group | Experimental | Dietary Supplement: Omega 3 Fish Oil supplementsParticipants 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. |
| Placebo Group | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3 Fish Oil supplementsParticipants 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. | Dietary supplement | Omega-3 Group |
| PlaceboParticipants 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 Group |
Primary outcome
Change in Retinal Artery Diameter
Time frame: Baseline, 3 Months 6 Months 9 Months
Change in retinal artery measured using OCTA
Change in Retinal Vein Diameter
Time frame: Baseline, 3 Months 6 Months 9 Months
Change in retinal vein diameter measured using OCTA
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.
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
3 secondary outcomes
Visual Acuity
Time frame: Baseline, 3 Months 6 Months 9 Months
Contrast Sensitivity
Time frame: Baseline, 3 Months 6 Months 9 Months
Blood Sugar Random, Glycosylated hemoglobin (HbA1c), Lipid Profile (Total cholesterol, HDL, LDL, Triglycerides)
Time frame: Baseline, 3 Months 6 Months 9 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Results publication: PubMed 39966603Sala-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.
- Results publication: PubMed 37862823Elbarbary 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.
- Official research portal of The University of Faisalabad, the sponsoring institution for this PhD study.Link provided by the sponsor.
- The Children's Hospital \& Institute of Child Health, LahoreLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3 Fish Oil supplements in people with Diabetic Retinopathy and Type 1 Diabetes, run by University of Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Retinal Artery Diameter (time frame: Baseline, 3 Months 6 Months 9 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07255326, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.