Trials / Completed
CompletedNCT04499820
Effect of OMEGA3 Supplementation in Diabetic Retinopathy
Effet d'Une supplémentation Par OMEGA3 Dans la rétinopathie diabétique
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Centre Hospitalier Intercommunal Creteil · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of this study is to evaluate the efficacy at 6 months of omega 3 supplementation on macular capillary density measured in optical coherence tomography angiography in patients with minimal or moderate non proliferative diabetic retinopathy.
Detailed description
Diabetic retinopathy (DR) is a leading cause of vision loss worldwide and is a major public health problem. In Western countries, the prevalence of DR is estimated to be 35% in diabetic patients, while diabetic macular edema (DME) affects 5% of them. Currently, apart from the balance of diabetes and other cardiovascular risk factors, no specific treatment is given for the minimal and moderate non-proliferative forms. * DHA concentration in the retina can be modified according to the patient's diet. * Minimal diabetic retinopathy does not currently benefit from specific treatment outside of diabetic control. * Omega 3 are already known for their beneficial effects on the retina, brain and cardiovascular system but their effectiveness has not been tested on diabetic retinopathy. * It is therefore a question of evaluating whether an omega 3 supplementation, at a dosage of 1000mg per day, can treat a minimal or moderate stage of diabetic retinopathy. A study by Salavila et al. has shown that the intake of LCω3PUFA, via a Mediterranean diet, improved the stage of DR in diabetic patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Nutrof | DHA docosahexaenoic acid Omega 3s may be of interest in cases of retinopathies. |
| DIETARY_SUPPLEMENT | Meralut | vitamin A, natural flavonoids, lutein and zeaxanthin |
Timeline
- Start date
- 2020-06-26
- Primary completion
- 2024-10-10
- Completion
- 2025-04-17
- First posted
- 2020-08-05
- Last updated
- 2025-12-04
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04499820. Inclusion in this directory is not an endorsement.