search
Back to results

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

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Citicoline
Docosahexaenoic Acid (DHA)
Citicoline and Docosahexaenoic Acid (DHA)
Vitamin C
Sponsored by
Institut Catala de Retina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glaucoma focused on measuring glaucoma, nutraceuticals, dha (docosahexaenoic acid), citicoline

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institut Catala de Retina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Citicoline

Docosahexaenoic Acid (DHA)

Citicoline and Docosahexaenoic Acid (DHA)

Vitamin C

Arm Description

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

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).

Cebrolux 800 and Brudypio 1.5g (see above).

Vitamin C.

Outcomes

Primary Outcome Measures

Effect on Mean Defect (MD)
Evaluation of changes on the MD (decibels) with study treatment.
Effect on Visual Field Index (VFI)
Evaluation of changes on the VFI (%) with study treatment.

Secondary Outcome Measures

Evaluation of the changes produced in the intraocular pressure (IOP)
To compare IOP (mmHg) measurements with study treatment.
Evaluation of tolerance
Describe the tolerance and the adverse events with study treatment.

Full Information

First Posted
August 29, 2022
Last Updated
September 1, 2022
Sponsor
Institut Catala de Retina
search

1. Study Identification

Unique Protocol Identification Number
NCT05527106
Brief Title
Evaluation of the Effect of Citicoline and Docosahexaenoic Acid (DHA) on the Visual Function of Patients With Glaucoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 12, 2015 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Catala de Retina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, nutraceuticals, dha (docosahexaenoic acid), citicoline

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Citicoline
Arm Type
Experimental
Arm Description
Cebrolux 800 is a food supplement based on citicoline (163 mg) that also contains vitamin A, E, C and B6.
Arm Title
Docosahexaenoic Acid (DHA)
Arm Type
Experimental
Arm 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).
Arm Title
Citicoline and Docosahexaenoic Acid (DHA)
Arm Type
Experimental
Arm Description
Cebrolux 800 and Brudypio 1.5g (see above).
Arm Title
Vitamin C
Arm Type
Experimental
Arm Description
Vitamin C.
Intervention Type
Dietary Supplement
Intervention Name(s)
Citicoline
Other Intervention Name(s)
Cebrolux 800
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Docosahexaenoic Acid (DHA)
Other Intervention Name(s)
Brudypio 1.5g
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Citicoline and Docosahexaenoic Acid (DHA)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
L-ascorbic acid
Intervention Description
Every subject randomized into this group have to take 1 pills of Vitamin C (500 mg per day), every day, for 3 months.
Primary Outcome Measure Information:
Title
Effect on Mean Defect (MD)
Description
Evaluation of changes on the MD (decibels) with study treatment.
Time Frame
From Baseline to Month 3.
Title
Effect on Visual Field Index (VFI)
Description
Evaluation of changes on the VFI (%) with study treatment.
Time Frame
From Baseline to Month 3.
Secondary Outcome Measure Information:
Title
Evaluation of the changes produced in the intraocular pressure (IOP)
Description
To compare IOP (mmHg) measurements with study treatment.
Time Frame
From Baseline to Month 3.
Title
Evaluation of tolerance
Description
Describe the tolerance and the adverse events with study treatment.
Time Frame
From Month 1 to Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfonso Anton, MD, PhD
Organizational Affiliation
Institut Catala de Retina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Catala de Retina
City
Barcelona
ZIP/Postal Code
08022
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs