Evaluation of the Effect of Citicoline and Docosahexaenoic Acid (DHA) on the Visual Function of Patients With Glaucoma

Study Overview
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Brief Summary
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Pilot, single-blind, randomized and controlled study to evaluate the changes produced in the visual function of patients with glaucoma after oral administration for 3 months of citicoline and docosahexaenoic Acid (DHA) vs citicoline and docosahexaenoic Acid (DHA) vs vitamin C.

Official Title
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Evaluation of the Effect of Citicoline (Cebrolux 800 mg) and Docosahexaenoic Acid (DHA) Compound (BrudyPio 1.5 g) on the Visual Function of Patients With Glaucoma With a Pilot Study

Conditions
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Glaucoma

Intervention / Treatment
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* Dietary Supplement: Citicoline
* Dietary Supplement: Docosahexaenoic Acid (DHA)
* Dietary Supplement: Citicoline and Docosahexaenoic Acid (DHA)
* Dietary Supplement: Vitamin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic, primary or secondary, open or closed angle glaucoma, diagnosed by meeting the following 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. There must be at least 3 reliable visual fields prior to the start of the study. Patients between 50 and 75 years old, homogeneously distributed among the groups. Glaucoma with functional and structural damage. Medium grade, Mean Deviation (MD) between -4 and -20 dB. In at least one eye. Exclusion Criteria: Treatment with some other vitamin or nutraceutical preparation. 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)). Hypersensitivity to aspirin. (Cross-allergic reaction has been reported in patients taking citicoline.) Allergic to fish protein. Eye surgery in the 3 months before or during the study.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Citicoline<br>Cebrolux 800 is a food supplement based on citicoline (163 mg) that also contains vitamin A, E, C and B6. | Dietary Supplement: Citicoline<br>* 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.<br>* Other names: Cebrolux 800;|
| Experimental: Docosahexaenoic Acid (DHA)<br>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). | Dietary Supplement: Docosahexaenoic Acid (DHA)<br>* 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.<br>* Other names: Brudypio 1.5g;|
| Experimental: Citicoline and Docosahexaenoic Acid (DHA)<br>Cebrolux 800 and Brudypio 1.5g (see above). | Dietary Supplement: Citicoline and Docosahexaenoic Acid (DHA)<br>* 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.<br>|
| Experimental: Vitamin C<br>Vitamin C. | Dietary Supplement: Vitamin C<br>* Every subject randomized into this group have to take 1 pills of Vitamin C (500 mg per day), every day, for 3 months.<br>* Other names: L-ascorbic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on Mean Defect (MD) | Evaluation of changes on the MD (decibels) with study treatment. | From Baseline to Month 3. | 
| Effect on Visual Field Index (VFI) | Evaluation of changes on the VFI (%) with study treatment. | From Baseline to Month 3. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the changes produced in the intraocular pressure (IOP) | To compare IOP (mmHg) measurements with study treatment. | From Baseline to Month 3. | 
| Evaluation of tolerance | Describe the tolerance and the adverse events with study treatment. | From Month 1 to Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, nutraceuticals, dha (docosahexaenoic acid), citicoline