Supplementation With a Highly-Concentrated Docosahexaenoic Acid (DHA) Triglyceride in Patients With Keratoconus

NCT ID: NCT05756062

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2022-01-10

Brief Summary

The goal of this randomized controlled preliminary study is to assess the effect of daily supplementation with a nutraceutical formulation of a highly-concentrated DHA triglyceride plus minerals on ophthalmological parameters and biomarkers of oxidative stress and inflammation in blood samples of patients with keratoconus.The main questions it aims to answer are:

• Improvements in ophthalmological parameters.
• Increase in antioxidant capacity, decrease in inflammatory status, and changes in lipidomic biomarkers.

Participants are patients with keratoconus who will be given the nutraceutical supplementation for 3 months.

If there is a comparison group: Researchers will compare patients with keratoconus not given the nutraceutical formulation to see differences in the study variables

Detailed Description

Among omega-3 polyunsaturated fatty acids (PUFAs), docosahexaenoic acid (DHA, C22:6-n3), a critical component of cell membrane phospholipids, exerts pleiotropic effects at both central and peripheral levels with health benefits in many aspects of neuronal, immune, cognitive, and cardiovascular functions Clinical studies of dietary sup-plementation with a highly-concentrated DHA triglyceride have shown consistent an-ti-inflammatory, antioxidant, antiangiogenic, and antiproliferative effects targeting pathophysiological pathways involved in different eye diseases, including diabetic retinopathy and macular edema, ocular surface disorders, meibomian gland dysfuncton, and pseudoexfoliative glaucoma.

Based on this experience, it was considered of interest to explore the antioxidant and anti-inflammatory potential of a highly-concentrated DHA triglyceride supplement in patients with keratoconus. For this purpose, a prospective preliminary study was designed to assess the effects of 3-month DHA nutritional supplementation on clinical variables, and inflammatory and oxidative stress biomarkers of patients with early and moderate keratoconus.

Conditions

Keratoconus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DHA group

Supplementation with a highly-concentrated docosahexaenoic acid (DHA) triglyceride (1000 g/day) for 3 months

Group Type: EXPERIMENTAL

Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%)

Intervention Type: DIETARY_SUPPLEMENT

Daily administration of 2 capsules of the study product (1000 mg DHA triglyceride) for 3 months

Control group

Routine care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%)

Daily administration of 2 capsules of the study product (1000 mg DHA triglyceride) for 3 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Diagnosis of keratoconus stages I to III according to the Amsler-Krumeich classification
• Non-contact lens wearers
• No history of previous corneal surgery
• Capacity to volunteer and willing and able to follow the study protocol

Exclusion Criteria

• Advanced keratoconus (stage IV of the Amsler-Krumeich classification
• Other ectasias (e.g. iatrogenic secondary to ocular surface surgery with excimer laser, radial keratotomy, traumatic corneal ectasia, etc.)
• Eyelid alterations
• Previous ocular surgery
• Any ocular or systemic condition that may affect the interpretation of results
• Glaucoma or ocular hypertension
• History of ocular trauma, infection or inflammation
• Current treatment with topical or anti-inflammatory drugs
• Use of nutritional supplements including omega-3 fatty acids, vitamins and minerals (unless a washout period of 1 month had been established)
• Hypersensitivity to fish proteins
• Pregnant women
• Refusal to sign the written informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

OTHER

Sponsor Role: lead

Responsible Party

Cristina Peris

Head Unit of Cornea and Anterior Eye Diseases, FISABIO Medical Ophthalmology (FOM)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristina Peris-Martinez, MD

Role: PRINCIPAL_INVESTIGATOR

FISABIO Medical Ophthalmology (FOM)

Locations

FISABIO Medical Ophthalmology (FOM)

Valencia, , Spain

Countries

Spain

Other Identifiers

PI_77

Identifier Type: -

Identifier Source: org_study_id