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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHA group | Experimental | Supplementation with a highly-concentrated docosahexaenoic acid (DHA) triglyceride (1000 g/day) for 3 months |
|
| Control group | No Intervention | Routine care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal topography | Changes of ophthalmological parameters | 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 | 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 | Baseline and after 3 months of supplementation (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristina Peris-Martinez, MD | FISABIO Medical Ophthalmology (FOM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FISABIO Medical Ophthalmology (FOM) | Valencia | 46015 | Spain |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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