Evaluation of the Effect of Citicoline and Docosahexaenoic Acid (DHA) on the Visual Function of Patients With Glaucoma
NCT ID: NCT05527106
Last Updated: 2022-09-02
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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COMPLETED
NA
73 participants
INTERVENTIONAL
2015-03-12
2022-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Citicoline
Cebrolux 800 is a food supplement based on citicoline (163 mg) that also contains vitamin A, E, C and B6.
Citicoline
Every subject randomized into this group have to take 2 sachets of Cebrolux 800 (362 mg of citicoline per day), every day, for 3 months.
Docosahexaenoic Acid (DHA)
Brudypio 1.5g is a food supplement based on Omega-3 fatty acid in the form of triglycerides (DHA 70% \[350 mg\], EPA 8.5%, DPA 6%) that also contains vitamins (A, B1, B2, B3, B6, B9, B12, C, E), carotenoids ( lutein, zeaxanthin, lycopene), glutathione, coenzyme Q10 and minerals (Zn, Se, Cu, Mn).
Docosahexaenoic Acid (DHA)
Every subject randomized into this group have to take 3 pills of Brudypio 1.5g (1050 mg of DHA per day), every day, for 3 months.
Citicoline and Docosahexaenoic Acid (DHA)
Cebrolux 800 and Brudypio 1.5g (see above).
Citicoline and Docosahexaenoic Acid (DHA)
Every subject randomized into this group have to take 2 sachets of Cebrolux 800 and 3 pills of Brudypio 1.5g per day, every day, for 3 months.
Vitamin C
Vitamin C.
Vitamin C
Every subject randomized into this group have to take 1 pills of Vitamin C (500 mg per day), every day, for 3 months.
Interventions
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Citicoline
Every subject randomized into this group have to take 2 sachets of Cebrolux 800 (362 mg of citicoline per day), every day, for 3 months.
Docosahexaenoic Acid (DHA)
Every subject randomized into this group have to take 3 pills of Brudypio 1.5g (1050 mg of DHA per day), every day, for 3 months.
Citicoline and Docosahexaenoic Acid (DHA)
Every subject randomized into this group have to take 2 sachets of Cebrolux 800 and 3 pills of Brudypio 1.5g per day, every day, for 3 months.
Vitamin C
Every subject randomized into this group have to take 1 pills of Vitamin C (500 mg per day), every day, for 3 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signs of structural damage: thinning of the optical nerve or peripapillary hemorrhage or decrease in the nerve fiber layer that can be seen by OCT.
* Signs of functional damage: 3 points outside 95% of the normal limit on the visual field pattern deviation graph.
2. There must be at least 3 reliable visual fields prior to the start of the study.
3. Patients between 50 and 75 years old, homogeneously distributed among the groups.
4. Glaucoma with functional and structural damage.
* Medium grade, Mean Deviation (MD) between -4 and -20 dB.
* In at least one eye.
Exclusion Criteria
2. Any pathology that can alter the visual field. (Neurological diseases, retinopathies, advanced cataract, patients treated with lyrica (due to the affectation it produces in the visual field)).
3. Hypersensitivity to aspirin. (Cross-allergic reaction has been reported in patients taking citicoline.)
4. Allergic to fish protein.
5. Eye surgery in the 3 months before or during the study.
50 Years
75 Years
ALL
No
Sponsors
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Institut Catala de Retina
OTHER
Responsible Party
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Principal Investigators
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Alfonso Anton, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut Catala de Retina
Locations
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Institut Catala de Retina
Barcelona, , Spain
Countries
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Other Identifiers
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ICR-14/13
Identifier Type: -
Identifier Source: org_study_id
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