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NCT05756062
Supplementation With a Highly-Concentrated Docosahexaenoic Acid (DHA) Triglyceride in Patients With Keratoconus
NA trial testing Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%) in Keratoconus in 34 participants. Completed in 10 January 2022.
10 January 2022
Quick facts
| Lead sponsor | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 34 |
| Start date | 1 February 2019 |
| Primary completion | 10 January 2022 |
| Estimated completion | 10 January 2022 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Highly-concentrated DHA triglyceride (Tridocosahexanoin-AOX 70%)
Conditions studied
- Keratoconus — all drugs for Keratoconus →
Sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana — full company profile →
Who can join
18 and older, any sex, with Keratoconus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05756062
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Keratoconus
Currently open trials in the same condition.
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- NCT07461129 — Electrophysiological Changes in Cases of Different Stages of Keratoconus · active not recruiting
- NCT06601101 — Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus · Phase 3 · recruiting
- NCT05516004 — Safety and Effectiveness of the PXL-Platinum 330 System for Cornea Crosslinking in Eyes With Cornea Thinning · Phase 2 · recruiting
- NCT06798779 — Predicting Manifest Astigmatism in Keratoconus Patients. · active not recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05756062 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Last refreshed: 6 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05756062.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing