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

NCT05756062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-03-06

No results posted yet for this study

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

Conditions

  • Keratoconus

Interventions

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Cristina Peris-Martinez, MD · FISABIO Medical Ophthalmology (FOM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2022-01-10
Completion
2022-01-10

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05756062 on ClinicalTrials.gov