Effect of OMEGA3 Supplementation in Diabetic Retinopathy
NCT ID: NCT04499820
Last Updated: 2022-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2020-06-26
2024-11-25
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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NUTROF Group
vitamin and DHA supplementation
Nutrof
DHA docosahexaenoic acid Omega 3s may be of interest in cases of retinopathies.
MERALUT Group
vitamin A, natural flavonoids, lutein and zeaxanthin and no DHA
Meralut
vitamin A, natural flavonoids, lutein and zeaxanthin
Interventions
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Nutrof
DHA docosahexaenoic acid Omega 3s may be of interest in cases of retinopathies.
Meralut
vitamin A, natural flavonoids, lutein and zeaxanthin
Eligibility Criteria
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Inclusion Criteria
* For women of childbearing age, an effective method of contraception is introduced and monitored throughout their participation in the study.
* Diabetic microangiopathy: minimal to moderate nonproliferative diabetic retinopathy according to the ETDRS (EarlyTreatment of DiabeticRetinopathyStudy) classification.
* AV \> 6/10
* One eye included. If both are affected, the eye with the poorer perfusion should be included.
* Affiliated to a social security scheme
Exclusion Criteria
* Pregnant or breastfeeding woman
* Other retinal pathologies that may interfere with the results (Patients previously treated with anti-VEGF, aflibercept or intra-vitreal corticosteroids, history of glaucoma, vitrectomy, retinal laser, epiretinal membrane), choroidal neo-vascularization, uveitis, retinal vascular occlusion, significant macular edema, macular thickness \> 280 µm, Eyes with spherical equivalent greater than 8 Diopters, OCTA images not interpretable with many artifacts.)
* Hypersensitivity to any of the components of Nutrof or Meralut
* Taking the antivitamin k
* Known deficit in G6PD-
* History of renal lithiasis
* Kidney failure
* Immunosuppression
* Chronic Ethylism
* History of hepatopathy
* Intracranial tumor, intracranial hypertension
* Refusal to participate
* Patient participating in an intervention study.
18 Years
ALL
No
Sponsors
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Laboratoires Thea
INDUSTRY
Centre Hospitalier Intercommunal Creteil
OTHER
Responsible Party
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Locations
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CHI Creteil
Créteil, Creteil, France
Countries
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Central Contacts
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Facility Contacts
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Eric SOUIED, MDH
Role: primary
Other Identifiers
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OMEDIA
Identifier Type: -
Identifier Source: org_study_id