KeratoconusNCT05756062
Supplementation With a Highly-Concentrated Docosahexaenoic Acid (DHA) Triglyceride in Patients With Keratoconus
A study testing Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%) in people with Keratoconus, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2019to 10 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antioxidant and Anti-inflammatory Effects of Oral Supplementation With a Highly-Concentrated Docosahexaenoic Acid (DHA) Triglyceride in Patients With Keratoconus: A Randomized Controlled Preliminary Study
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.
Read more
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
Read the detailed 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.
- Conditions
- Keratoconus
- Being tested
- Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%)
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| DHA group | Experimental | Supplementation with a highly-concentrated docosahexaenoic acid (DHA) triglyceride (1000 g/day) for 3 months Receives: Dietary Supplement: Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%) |
| Control group | No intervention | Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal topography
Changes of ophthalmological parameters
Measured: 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
Measured: 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
Measured: Baseline and after 3 months of supplementation (end of study)
Secondary outcomes (1)
Lipidomic variables
Serum levels of DHA, arachidonic acid (ARA), n-6 PUFA/n-3 PUFA, omega-3 index
Measured: Baseline and after 3 months of supplementation (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Feb 2019
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Peris, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Investigators
- Cristina Peris-Martinez, MD, Principal investigator, FISABIO Medical Ophthalmology (FOM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756062
- Sponsor's protocol ID
- PI_77
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antioxidant and Anti-inflammatory Effects of Oral Supplementation With a Highly-Concentrated Docosahexaenoic Acid (DHA) Triglyceride in Patients With Keratoconus: A Randomized Controlled Preliminary Study
- ClinicalTrials.gov ID
- NCT05756062
- Acronym / sponsor ID
- PI_77
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA group | Experimental | Dietary Supplement: Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%)Supplementation with a highly-concentrated docosahexaenoic acid (DHA) triglyceride (1000 g/day) for 3 months |
| Control group | No intervention | –Routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%)Daily administration of 2 capsules of the study product (1000 mg DHA triglyceride) for 3 months | Dietary supplement | DHA group |
Primary outcome
Corneal topography
Time frame: Baseline and after 3 months of supplementation (end of study)
Changes of ophthalmological parameters
Antioxidant variables
Time frame: Baseline and after 3 months of supplementation (end of study)
Changes in plasma total antioxidant capacity (TAC), malondialdehyde (MDA) and glutathione (GSH), and GSH/GSSH ratio
Anti-inflammatory variables
Time frame: Baseline and after 3 months of supplementation (end of study)
cytokine levels IL-1beta, IL-4, IL-6, IL-10, IL-18, TNFalpha, VEGF-A
1 secondary outcome
Lipidomic variables
Time frame: Baseline and after 3 months of supplementation (end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Peris-Martinez, MD principal investigator
FISABIO Medical Ophthalmology (FOM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%) in people with Keratoconus, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal topography (time frame: Baseline and after 3 months of supplementation (end of study)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.