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

Institut Catala de Retina

Status: Completed

Conditions: Glaucoma

Treatments: Dietary Supplement: Docosahexaenoic Acid (DHA); Dietary Supplement: Vitamin C; Dietary Supplement: Citicoline; Dietary Supplement: Citicoline and Docosahexaenoic Acid (DHA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05527106

ICR-14/13

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.

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

1. Treatment with some other vitamin or nutraceutical preparation.
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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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73 participants in 4 patient groups

Citicoline

Experimental group

Description:

Cebrolux 800 is a food supplement based on citicoline (163 mg) that also contains vitamin A, E, C and B6.

Treatment:

Dietary Supplement: Citicoline

Docosahexaenoic Acid (DHA)

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Docosahexaenoic Acid (DHA)

Citicoline and Docosahexaenoic Acid (DHA)

Experimental group

Description:

Cebrolux 800 and Brudypio 1.5g (see above).

Treatment:

Dietary Supplement: Citicoline and Docosahexaenoic Acid (DHA)

Vitamin C

Experimental group

Description:

Vitamin C.

Treatment:

Dietary Supplement: Vitamin C