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

Keratoconus Clinical Trial

Official title:

Antioxidant and Anti-inflammatory Effects of Oral Supplementation With a Highly-Concentrated Docosahexaenoic Acid (DHA) Triglyceride in Patients With Keratoconus: A Randomized Controlled Preliminary Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05756062
• Other study ID #: PI_77
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: January 10, 2022

Study information

• Verified date: February 2023
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

Dietary Supplement:
• Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%)
Daily administration of 2 capsules of the study product (1000 mg DHA triglyceride) for 3 months

Locations

Country	Name	City	State
Spain	FISABIO Medical Ophthalmology (FOM)	Valencia

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal topography	Changes of ophthalmological parameters	Baseline and after 3 months of supplementation (end of study)
Primary	Antioxidant variables	Changes in plasma total antioxidant capacity (TAC), malondialdehyde (MDA) and glutathione (GSH), and GSH/GSSH ratio	Baseline and after 3 months of supplementation (end of study)
Primary	Anti-inflammatory variables	cytokine levels IL-1beta, IL-4, IL-6, IL-10, IL-18, TNFalpha, VEGF-A	Baseline and after 3 months of supplementation (end of study)
Secondary	Lipidomic variables	Serum levels of DHA, arachidonic acid (ARA), n-6 PUFA/n-3 PUFA, omega-3 index	Baseline and after 3 months of supplementation (end of study)