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Effect of Antioxidant Docosahexaenoic Acid (DHA) in Cystic Fibrosis Patients | Clinical Trials | Clareo Health

COMPLETEDNA

Effect of Antioxidant Docosahexaenoic Acid (DHA) in Cystic Fibrosis Patients

Effect of Antioxidant Docosahexaenoic Acid (DHA) Supplementation in Cystic Fibrosis Patients: A Randomized Placebo-controlled Trial

NCT04987567•Corporacion Parc Tauli

View on ClinicalTrials.gov

Summary

This study evaluates the effect of antioxidant docosahexaenoic acid (DHA) in patients with cystic fibrosis. Half of participants will receive DHA, while the other half will receive placebo.

Detailed Description

Several studies show that patients with cystic fibrosis (CF) usually have, compared to the normal population, low levels of linoleic acid (LA) and docosahexaenoic acid (DHA) and increase in arachidonic acid (AA), which is pro-inflammatory. Normalization or modification of this fatty acid pattern (AP) could reduce chronic inflammation. The aim of this study is to assess the effect of oral supplementation with DHA for one year in pediatric patients (6-18 years) with CF, on inflammatory parameters, AP profile, lung function (spirometry) and number of exacerbations.

Eligibility

Age

6 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients of both genders with a diagnosis of cystic fibrosis.
•FEV1 \> 40%.
•Age between 6 and 18 years.
•Patients who grant their informed consent or whose representative grants informed consent to participate in the study.

Exclusion Criteria

•Pregnant or breastfeeding women
•Basal oxygen saturation \<92% or household supplemental oxygen needs.
•Massive hemoptysis
•Patients who are not able to follow or who cannot be assessed in the study according to the protocol.
•Any circumstance that, at the discretion of the doctor, may involve a clinical risk or harm, the patient's participation in the study or that interferes with the evaluation of the same.
•Use of systemic glucocorticoids or in the 4 weeks prior to inclusion in the study.
•Use of non-steroidal anti-inflammatory drugs in the 2 weeks prior to inclusion in the study.
•Use of investigational drugs or participation in another clinical trial within 30 days prior to inclusion in the study or within the 5 elimination half-lives of the investigational drug.
•Be already supplementing with Omega -3, fish oil or DHA

Locations (1)

Parc Tauli Hospital

Sabadell, Barcelona, Spain

Key Dates

Start Date

March 21, 2018

Primary Completion Date

February 20, 2020

Completion Date

February 20, 2020

Last Updated

August 3, 2021

Enrollment

ACTUAL participants

Conditions

Cystic Fibrosis in Children

Interventions

ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®)

DIETARY_SUPPLEMENT

PLACEBO (OLIVE OIL)

DIETARY_SUPPLEMENT

Feasibility of Cough Monitoring in Children

NCT06587126

Cystic Fibrosis in Children

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COMPLETEDNA

Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

NCT04084041

Cystic Fibrosis in ChildrenAirway Clearance Impairment

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COMPLETEDPHASE4

Efficacy of Intensive Cholecalciferol Monitoring and Supplementation on Serum vitD Levels in Pediatric Patients With CF

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effect of Antioxidant Docosahexaenoic Acid (DHA) in Cystic Fibrosis Patients

Inclusion Criteria

Exclusion Criteria

Feasibility of Cough Monitoring in Children

Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

Efficacy of Intensive Cholecalciferol Monitoring and Supplementation on Serum vitD Levels in Pediatric Patients With CF

Viral Infections and Airway Microbiome in Young Children With Cystic Fibrosis

Effect of Lumacaftor/Ivacaftor in Children With Cystic Fibrosis Homozygote for F508del on Small Airway Function

Percussion Palm Cup: Safety and Usability in Infants and Children With Cystic Fibrosis