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NCT Number: NCT05756062

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

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

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FISABIO Medical Ophthalmology (FOM)

Valencia, 46015, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

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

Primary outcomes

  1. Corneal topography

    Time frame: Baseline and after 3 months of supplementation (end of study)

    Changes of ophthalmological parameters

  2. Antioxidant variables

    Time frame: 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

  3. Anti-inflammatory variables

    Time frame: 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 outcomes

  1. Lipidomic variables

    Time frame: 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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 6, 2023
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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