Clinical trial NCT04987567: Effect of Antioxidant Docosahexaenoic Acid (DHA) in Cystic Fibrosis Patients
Official title: Effect of Antioxidant Docosahexaenoic Acid (DHA) Supplementation in Cystic Fibrosis Patients: A Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis in Children
Keywords: cystic fibrosis
Docosahexaenoic Acid
fatty acids
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Is not a drug, is a food supplement.
Primary purpose: SUPPORTIVE_CARE

Brief 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 criteria: 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

Primary outcomes:
measure: Change from Baseline Fatty Acid (FA) profile (percentage) of the erythrocyte membrane at 6 and 12 months
timeFrame: baseline, 6 month and 12 month of treatment (end of study)
Secondary outcomes:
measure: Change from Baseline Serum interleukins at 12 months
timeFrame: baseline and 12 month of treatment (end of study)
measure: Change from baseline pulmonary function at 3,6 ,9 and 12 months
timeFrame: baseline, 3 months, 6 month, 9 months and 12 month of treatment (end of study)
measure: Number of Pulmonary exacerbation during the study year compared with previous years
timeFrame: 12 months prior study, 12 months of the study
measure: Change from baseline fecal calprotectin at the 12 months
timeFrame: Baseline and 12 months
measure: Adverse reactions during the study
timeFrame: baseline, 3, 6 , 9 and 12 month of treatment (end of study)
measure: Change from Baseline Esputum interleukins at 6 and 12 months
timeFrame: baseline and 12 months
measure: Change from baseline differencial cell counts in sputum at 6 and 12 months.
timeFrame: baseline, 6 months and 12 monts
measure: Change from baseline weight at 3, 6, 9 and 12 months
timeFrame: Baseline, 3,6,9 and 12 months
measure: Change from baseline height at 3, 6, 9 and 12 months
timeFrame: Baseline, 3,6,9 and 12 months
measure: Change from baseline body mass index (BMI) at 3, 6, 9 and 12 months
timeFrame: Baseline, 3,6,9 and 12 months
measure: Change from Baseline FA ratios of the erythrocyte membrane at 6 and 12 months
timeFrame: baseline, 6 months and 12 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Parc Tauli Hospital
state: Barcelona
Study officials:
affiliation: Parc Tauli Hospital from Sabadell (Barcelona). Spain.
name: Roser Ayats Vidal, MD
role: PRINCIPAL_INVESTIGATOR
References: