Supplementation With a Highly-Concentrated Docosahexaenoic Acid (DHA)

Status Completed

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Keratoconus

Clinical Trial Details

NCT number	NCT05756062
Study type	Interventional
Source	Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Contact
Status	Completed
Phase	N/A
Start date	February 1, 2019
Completion date	January 10, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms