An interventional study of Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%) in Keratoconus, sponsored by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-06.
Sponsored by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · Not applicable, Interventional, and Treatment
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:
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
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.
307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 34 is below the median of 40 across 203 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana is the lead sponsor of 43 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Supplementation with a highly-concentrated docosahexaenoic acid (DHA) triglyceride (1000 g/day) for 3 months
Dietary Supplement: Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%)
Routine care
Daily administration of 2 capsules of the study product (1000 mg DHA triglyceride) for 3 months
Corneal topography
Changes of ophthalmological parameters
Time frame: Baseline and after 3 months of supplementation (end of study)
Antioxidant variables
Changes in plasma total antioxidant capacity (TAC), malondialdehyde (MDA) and glutathione (GSH), and GSH/GSSH ratio
Time frame: Baseline and after 3 months of supplementation (end of study)
Anti-inflammatory variables
cytokine levels IL-1beta, IL-4, IL-6, IL-10, IL-18, TNFalpha, VEGF-A
Time frame: Baseline and after 3 months of supplementation (end of study)
Lipidomic variables
Serum levels of DHA, arachidonic acid (ARA), n-6 PUFA/n-3 PUFA, omega-3 index
Time frame: Baseline and after 3 months of supplementation (end of study)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana