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

Not Applicable

Completed

• Conditions: Keratoconus
• Interventions: Dietary Supplement: Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%)

• Registration Number: NCT05756062
• Lead Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2022-01-10
• Study Completion: 2022-01-10
• Status Verified: 2023-02
• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-23
• Last Update Submitted: 2023-02-23
• Study First Posted: 2023-03-06
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHA group	Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%)	Supplementation with a highly-concentrated docosahexaenoic acid (DHA) triglyceride (1000 g/day) for 3 months

Primary Outcome Measures

Name	Time	Method
Corneal topography	Baseline and after 3 months of supplementation (end of study)	Changes of ophthalmological parameters
Antioxidant variables	Baseline and after 3 months of supplementation (end of study)	Changes in plasma total antioxidant capacity (TAC), malondialdehyde (MDA) and glutathione (GSH), and GSH/GSSH ratio
Anti-inflammatory variables	Baseline and after 3 months of supplementation (end of study)	cytokine levels IL-1beta, IL-4, IL-6, IL-10, IL-18, TNFalpha, VEGF-A

Secondary Outcome Measures

Name	Time	Method
Lipidomic variables	Baseline and after 3 months of supplementation (end of study)	Serum levels of DHA, arachidonic acid (ARA), n-6 PUFA/n-3 PUFA, omega-3 index

Trial Locations

Locations (1)

FISABIO Medical Ophthalmology (FOM); 🇪🇸 Valencia, Spain