NCT05756062

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
Last Updated

March 6, 2023

Status Verified

February 1, 2023

Enrollment Period

2.9 years

First QC Date

February 9, 2023

Last Update Submit

February 23, 2023

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (3)

  • 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)

Secondary Outcomes (1)

  • Lipidomic variables

    Baseline and after 3 months of supplementation (end of study)

Study Arms (2)

DHA group

EXPERIMENTAL

Supplementation with a highly-concentrated docosahexaenoic acid (DHA) triglyceride (1000 g/day) for 3 months

Dietary Supplement: Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%)

Control group

NO INTERVENTION

Routine care

Interventions

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

DHA group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FISABIO Medical Ophthalmology (FOM)

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Cristina Peris-Martinez, MD

    FISABIO Medical Ophthalmology (FOM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Unit of Cornea and Anterior Eye Diseases, FISABIO Medical Ophthalmology (FOM)

Study Record Dates

First Submitted

February 9, 2023

First Posted

March 6, 2023

Study Start

February 1, 2019

Primary Completion

January 10, 2022

Study Completion

January 10, 2022

Last Updated

March 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)