Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-22 @ 1:20 PM
Study NCT ID:
NCT05527106
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2022-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Citicoline and Docosahexaenoic Acid (DHA) on the Visual Function of Patients With Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003566', 'term': 'Cytidine Diphosphate Choline'}, {'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D002794', 'term': 'Choline'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D003565', 'term': 'Cytidine Diphosphate'}, {'id': 'D003597', 'term': 'Cytosine Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2022-08-29', 'studyFirstSubmitQcDate': '2022-09-01', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect on Mean Defect (MD)', 'timeFrame': 'From Baseline to Month 3.', 'description': 'Evaluation of changes on the MD (decibels) with study treatment.'}, {'measure': 'Effect on Visual Field Index (VFI)', 'timeFrame': 'From Baseline to Month 3.', 'description': 'Evaluation of changes on the VFI (%) with study treatment.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the changes produced in the intraocular pressure (IOP)', 'timeFrame': 'From Baseline to Month 3.', 'description': 'To compare IOP (mmHg) measurements with study treatment.'}, {'measure': 'Evaluation of tolerance', 'timeFrame': 'From Month 1 to Month 3', 'description': 'Describe the tolerance and the adverse events with study treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glaucoma', 'nutraceuticals', 'dha (docosahexaenoic acid)', 'citicoline'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with chronic, primary or secondary, open or closed angle glaucoma, diagnosed by meeting the following criteria:\n\n * 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.\n * Signs of functional damage: 3 points outside 95% of the normal limit on the visual field pattern deviation graph.\n2. There must be at least 3 reliable visual fields prior to the start of the study.\n3. Patients between 50 and 75 years old, homogeneously distributed among the groups.\n4. Glaucoma with functional and structural damage.\n\n * Medium grade, Mean Deviation (MD) between -4 and -20 dB.\n * In at least one eye.\n\nExclusion Criteria:\n\n1. Treatment with some other vitamin or nutraceutical preparation.\n2. 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)).\n3. Hypersensitivity to aspirin. (Cross-allergic reaction has been reported in patients taking citicoline.)\n4. Allergic to fish protein.\n5. Eye surgery in the 3 months before or during the study.'}, 'identificationModule': {'nctId': 'NCT05527106', 'briefTitle': 'Evaluation of the Effect of Citicoline and Docosahexaenoic Acid (DHA) on the Visual Function of Patients With Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Institut Catala de Retina'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ICR-14/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Citicoline', 'description': 'Cebrolux 800 is a food supplement based on citicoline (163 mg) that also contains vitamin A, E, C and B6.', 'interventionNames': ['Dietary Supplement: Citicoline']}, {'type': 'EXPERIMENTAL', 'label': 'Docosahexaenoic Acid (DHA)', '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).', 'interventionNames': ['Dietary Supplement: Docosahexaenoic Acid (DHA)']}, {'type': 'EXPERIMENTAL', 'label': 'Citicoline and Docosahexaenoic Acid (DHA)', 'description': 'Cebrolux 800 and Brudypio 1.5g (see above).', 'interventionNames': ['Dietary Supplement: Citicoline and Docosahexaenoic Acid (DHA)']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin C', 'description': 'Vitamin C.', 'interventionNames': ['Dietary Supplement: Vitamin C']}], 'interventions': [{'name': 'Citicoline', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Cebrolux 800'], '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.', 'armGroupLabels': ['Citicoline']}, {'name': 'Docosahexaenoic Acid (DHA)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Brudypio 1.5g'], '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.', 'armGroupLabels': ['Docosahexaenoic Acid (DHA)']}, {'name': 'Citicoline and Docosahexaenoic Acid (DHA)', 'type': 'DIETARY_SUPPLEMENT', '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.', 'armGroupLabels': ['Citicoline and Docosahexaenoic Acid (DHA)']}, {'name': 'Vitamin C', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['L-ascorbic acid'], 'description': 'Every subject randomized into this group have to take 1 pills of Vitamin C (500 mg per day), every day, for 3 months.', 'armGroupLabels': ['Vitamin C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08022', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Institut Catala de Retina', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Alfonso Anton, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Catala de Retina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Catala de Retina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}